The FDA today published a warning letter it sent to epidural and anesthesia needle maker International Medical Development over issues with it marketing its Gertie Marx needles outside its indication and quality control issues related to manufacturing.
International Medical Development’s Gertie Marx needles are cleared for “the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter in adults,” according to the FDA.
The federal watchdog said the company is marketing the needles for lumbar puncture, myelogram and pediatric use, which it said the company lacks clearance or approval for.
The agency referenced 4 cases in which International Medical Development’s website, promotional material and outer packaging mis-represented their indicated uses, referring to the devices as “needles for Lumbar Punctures,” “an invaluable tool for . . . pediatric anesthesiologists and neurologists,” and other pediatric and lumbar uses.
The FDA also knocked International Medical Development on its manufacturing quality control systems, noting 5 specific areas where the company was failing to meet the agency’s requirements.
International Medical Development was hit for failing to establish and maintain procedures to control non-conforming products. The agency said the company had “failed to document any nonconforming product” but said 9 device history records reviewed by investigators found “labeling errors or discrepancies.”
The federal watchdog said the company had exhibited a “failure to establish records of acceptable suppliers, contractors and consultants,” and that after reviewing audit reports found incomplete documentation pertaining to the “type and extend of control to be exercised over them.”
The FDA hit the company on 3 more points, saying it had failed to document, establish and maintain procedures for acceptance activities, failed to maintain an “adequate device history record,” and failed to maintain an adequate device master record, according to the letter.
The agency requested International Medical Development correct the errors in quality control and either submit applications for extended indications or desist in marketing its needles outside their indications.