NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: ACTUAL EVENT DATE ADDED BASED ON INFO FROM CUSTOMER. INVESTIGATION RESULTS: ELEVEN SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THE SAMPLES WERE SENT FOR VISUAL INSPECTION AND TESTING. UPON THE EVALUATION, THE REPORTED FAILURE WAS NOT OBSERVED IN THESE NEEDLES. THE REPORTED INCIDENT COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED AS THE FAILURE COULD NOT BE VERIFIED. BD SPINAL NEEDLES COME IN DIFFERENT GAUGE SIZES, 18GA (THICKER) UP TO 27GA (THINNER). BASED ON PRODUCT INTENDED USE, THINNER GAGES ARE RECOMMENDED TO BE USED WITH AN INTRODUCER NEEDLE IN WHICH ASSISTS IN THE PLACEMENT OF SPINAL NEEDLES. IN (B)(4) 2024 AS PART OF A PROJECT, A CHANGE WAS IMPLEMENTED TO ALL LABELING LEVELS A UNIT CONVERSION FROM INCH TO MM IN NEEDLE LENGTH CONFIGURATIONS (DECIMAL NUMBERS). THIS CHANGE DID NOT IMPACT THE PRODUCT BECAUSE THE LENGTH OF THE NEEDLE IS THE SAME BUT, REFLECTED IN DECIMAL NUMBERS. ALSO, IN MAY 2024 A RESIN COLOR CHANGE IN THE HANDLE OF THE STYLET WAS IMPLEMENTED DUE TO REGULATIONS. UPDATES TO THE BD WEBSITE WAS ALSO REQUESTED TO ALIGN WITH THESE CHANGES. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

Description of Event or Problem

ADDITIONAL INFORMATION ON EVENT FROM CUSTOMER: I HAD A CHANCE TO SPEAK WITH THE RADIOLOGIST WHO HAS EXPERIENCED THE ISSUE. MY UNDERSTANDING IS THEY ARE INJECTING PAIN MEDS INTO THE FACET JOINTS ALONG THE SPINE. THIS PROCEDURE IS EXECUTED UNDER FLUOROSCOPY. PROCEDURE DONE IN RADIOLOGY VERDUN AND NOTRE DAME IN MONTREAL HE MENTIONED THE STYLET IS IN WHEN ADVANCING THE NEEDLE OFTEN STRIKE BONE TO VALIDATE POSITIONING ¿ MOVE THE NEEDLE BACK A TOUCH, PULL THE STYLET AND INJECT THEY NEVER REUSE OR ADVANCE THE NEEDLE ONCE IT IS IN PLACE PROBLEM WITH BLOCKAGE STARTED ONCE THE HUB COLOR CHANGED. SOUNDS LIKE A COINCIDENCE. THEY HAVE A LONG HISTORY USING THIS NEEDLE FOR THIS APPLICATION. I ASKED ONCE HE PULLS THE NEEDLE OUT HAS, HE CHECKED FOR PATENCY ¿ HE SAID THEY HAVE AND THEY ARE BLOCKED. PROBLEM STILL ONGOING AS OF YESTERDAY. I RECOMMENDED OUR 23G QUINCKE TO SEE IF THAT HELPS.

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

Description of Event or Problem

MATERIAL: 405180. BATCH#: 4278395. VERBATIM: CLINICAL TEAM HAS NOT BEEN ABLE TO INJECT THROUGH THE NEEDLE DISCARD NEEDLE AND TRY ANOTHER ONE. REPORTED THE ISSUE TO BE INTERMITTENT NO ADVERSE EVENT HAS OCCURRED OR PATIENT INJURY NOTED JUST INCONVENIENT, TIME WASTING AND ADDS A POKE TO THE PATIENT WHICH IS NOT IDEAL PRACTICE ADDITIONAL INFORMATION 14 FEBRUARY THE DISTRIBUTOR'S RESPONSE TO THIS CLOSURE LETTER CONFIRMS THAT, YES, THE ISSUE IS THAT THE NEEDLES ARE BLOCKED, NOT INJECTING, OCCLUDED. THEY THINK THE COLOR CHANGE MAY BE RELATED TO THESE ISSUES.