NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE

Additional Manufacturer Narrative

H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. LOT NUMBERS WERE NOT REPORTED; HOWEVER, POTENTIAL LOT NUMBERS WERE PROVIDED, 4271991, 4183543, 4242354.

Description of Event or Problem

IT IS REPORTED BROKEN NEEDLE, LEAVING FRAGMENTS IN PATIENTS BACK. EVENT DESCRIPTION: (B)(6) 2025, WHILE PERFORMING A SPINAL PUNCTURE ON A PT FOR AN ELECTIVE C-SECTION, THE SPINAL NEEDLE 27G WHITACRE BROKE, LEAVING A FRAGMENT IN THE PT'S BACK. WE UNFORTUNATELY DO NOT HAVE THE PACKAGING BUT DO HAVE THE BROKEN END OF THE NEEDLE. WE LOOKED THROUGH THE DRAWER WHERE WE RETRIEVED THE NEEDLE AND WE HAVE 3 POSSIBLE LOT S 4271991, 4183543, 4242354. THE PATIENT RETURNED TO THE OR THE NEXT DAY TO HAVE THE FRAGMENT SURGICALLY REMOVED. ADDITIONAL INFORMATION: PLEASE NOTE THAT THERE WAS SURGICAL INTERVENTION AS CONSEQUENCE OF THE REPORTED INCIDENT. THE PATIENT IS RECOVERING WELL AFTER THE NEEDLE FRAGMENT WAS REMOVED YESTERDAY, WITH SURGERY AND A GENERAL ANESTHETIC. SHE HAS NO NEUROLOGIC SYMPTOMS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: THREE PHOTOS WERE RECEIVED BY OUR QUALITY TEAM EVALUATION. UPON EVALUATION, THE IMAGES SHOW A BENT AND BROKEN FRAGMENT OF A NEEDLE; THEREFORE, THE REPORTED INCIDENT WAS VERIFIED BASED ON THE VISUAL EVIDENCE RECEIVED. A PHYSICAL SAMPLE WAS SENT IN; HOWEVER, WE ARE UNABLE TO LOCATE IT CURRENTLY. SHOULD THE SAMPLE BE LOCATED, WE WILL RE-INVESTIGATE AND RESPOND BACK TO YOU WITH THE ADDITIONAL RESULTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE THREE POTENTIAL LOTS PROVIDED AND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE WERE FOUND DURING PRODUCTION OF THIS BATCH. BD JUNCOS MANUFACTURES SPINAL NEEDLES OF 18GA (THICKER) UP TO 27GA (THINNER). BASED ON PRODUCT INTENDED USE, THINNER GAGES ARE RECOMMENDED TO BE USED WITH AN INTRODUCER NEEDLE WHICH ASSISTS IN THE PLACEMENT OF SPINAL NEEDLES. AS IS EXPLAINED IN THE INSTRUCTIONS FOR USE (IFU), CARE SHOULD BE TAKEN TO AVOID NEEDLE DAMAGE. NOT ATTEMPTING TO STRAIGHTEN A BENT NEEDLE. REPEATED POSITIONING MAY INCREASE THE RISK OF NEEDLE BREAKAGE AND THEREFORE IT IS NOT RECOMMENDED. OBSERVE NEEDLE CAREFULLY DURING PROCEDURES AND TO BE USED BY PROPERLY QUALIFIED AND TRAINED HEALTH PROFESSIONALS. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.