PORTEX TUOHY EPIDURAL NEEDLES

Additional Manufacturer Narrative

H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS STATED THAT WHEN AN EPIDURAL WAS ADMINISTERED TO THE PATIENT, THE 11CM TUOHY NEEDLE LOCATED THE EPIDURAL SPACE AT 7.5CM WITHOUT BLEEDING OR CEREBROSPINAL FLUID (CSF) REFLUX. AN ATTEMPT WAS THEN MADE TO ADVANCE THE CATHETER WHICH REPEATEDLY STOPPED AT APPROXIMATELY 7 CM. THE NEEDLE WAS EVENTUALLY WITHDRAWN, BUT IT BROKE AT THE LEVEL OF SKIN INSERTION, LEAVING 7.5 CM OF THE NEEDLE LODGED IN THE SPINAL COLUMN. THE ENTIRE PIECE OF THE NEEDLE EMBEDDED IN THE EPIDURAL SPACE WAS SUCCESSFULLY RETRIEVED, COMING OUT INTACT WITH NO RESIDUAL FRAGMENTS LEFT IN THE PATIENT. A SECOND EPIDURAL PUNCTURE WAS THEN PERFORMED IN THE L3-L4 SPACE. THE SPACE WAS AGAIN FOUND AT 7.5 CM, AND THE CATHETER WAS SUCCESSFULLY ADVANCED WITHOUT ISSUES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

H6: EVALUATION CODES UPDATED. ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED COMPLAINT WAS CONFIRMED. BASED ON THE CONDITION OF THE SAMPLES AND THE COMPLAINT EVENT DESCRIPTION, IT APPEARS THAT THE NEEDLE BENT/BROKE DUE TO EXCESSIVE FORCE BEING APPLIED TO IT. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

Additional Manufacturer Narrative

D2B - PROCODE; CORRECTED.