ARROW SPINAL ANESTHESIA KIT

Additional Manufacturer Narrative

(B)(4). ADDITIONAL INFORMATION RECEIVED 05JUN2024 STATES "NEEDLE RECOGNIZED BROKEN OFF IMMEDIATELY; NEEDLE REMOVED WITH NO ISSUES; AS STATED...THE PATIENT IS FINE. THE FACT THAT THE NEEDLE BROKE ON THIS ROUTINE MATTER PROMPTED US TO VOLUNTARILY REPORT." COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS. CORRECTED DATA: SECTION D.4. - UNIQUE IDENTIFIER (UDI)# CORRECTED TO (B)(4).

Description of Event or Problem

IT WAS REPORTED "WHEN SPINAL NEEDLE REMOVED (C-SECTION PREP), APPROXIMATELY 4-5 CM OF NEEDLE MISSING, BROKEN OFF IN PATIENT. REQUIRED NEW SPINAL. REMOVAL DONE OF THE RFB (NEEDLE) AFTER DELIVERY OF THE BABY. SEPARATE PROCEDURE."

Additional Manufacturer Narrative

QN#(B)(4).

Description of Event or Problem

IT WAS REPORTED "WHEN SPINAL NEEDLE REMOVED (C-SECTION PREP), APPROXIMATELY 4-5 CM OF NEEDLE MISSING, BROKEN OFF IN PATIENT. REQUIRED NEW SPINAL. REMOVAL DONE OF THE RFB (NEEDLE) AFTER DELIVERY OF THE BABY. SEPARATE PROCEDURE." ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.