BD CONVENTIONAL NEEDLES
Report
- Report Number
- 3002682307-2024-00268
- Event Type
- Malfunction
- Date Received
- January 14, 2025
- Date of Event
- December 26, 2024
- Report Date
- March 20, 2025
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- UDI-DI
- 00382903040001
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS (B)(4). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: CONVENTIONAL NEEDLES. DEVICE FAILURE: NEEDLE DAMAGED / DEFECTIVE.
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 240701. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE AND TWO (2) PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, ONE (1) NEEDLE IS OBSERVED WITH THE CORRECT LENGTH AND A WELL-FORMED BEVEL, AND THE OTHER NEEDLE IS SHORTER WITHOUT A CANNULA BEVEL. THROUGH MICROSCOPIC EXAMINATION OF THE SHORTER NEEDLE, IT SEEMS THE NEEDLE HAS BEEN BROKEN. CONSIDERING THE PROVIDED INFORMATION OF ¿THE CANNULAS SHOWED MANUFACTURING FAULTS WHICH COULD BE SEEN AFTER USE¿ WE UNDERSTAND THAT THE CANNULA WAS NOT BROKEN BEFORE USE. THEREFORE, WE CANNOT EXCLUDE THAT THE HANDLING OF THE PRODUCT HAD SOME IMPLICATION IN THIS EVENT. AT THIS TIME, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS ISSUE. WE WOULD LIKE TO INFORM YOU THAT THE CANNULAS USED FOR THE MANUFACTURE OF THIS PRODUCT COMPLY WITH ISO STANDARD ISO 9626 ¿STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES¿. IN ACCORDANCE, ANY ISSUES OF BREAKAGE ARE VERY RARE UNLESS SOME INAPPROPRIATE USES OF THE PRODUCT WERE TO OCCUR, FOR SAMPLE, BENDING OF THE NEEDLE DURING USE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES NEEDLE IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE ARE REPORTING 2 INCIDENTS INVOLVING BD MICROLANCE 3 30G X ½¿¿ (0.3X13MM) CANULAS REF (B)(4). ON 2 OCCASIONS WITH TWO DIFFERENT PATIENTS, DURING INJECTIONS OF PRODUCTS, THE CANULAS SHOWED MANUFACTURING FAULTS WHICH COULD BE SEEN AFTER USE: THEY WERE SHORTER AND SLIGHTLY TWISTED WITH A TIP WITHOUT THE CORRECT BEVEL. PHOTOS OF A NORMAL AND A FAULTY CANULA ARE ATTACHED. THE PRODUCTS, BEING OF VERY SMALL VOLUME, COULD NOT BE INJECTED AND WERE LOST. THESE ARE LUCENTIS WITH A PRE-FILLED SYRINGE ON WHICH A BD CANULA IS POSITIONED, WITH THE AIR IN THE CANULA PURGED. ON THE FIRST OCCASION, THE PRACTITIONER DID NOT KEEP THE CANULA. THE SECOND TIME THE CANULA WAS KEPT AND IS AVAILABLE FOR EXPERT EXAMINATION. THIS WAS BATCH 240701, EXPIRY DATE 2029-06. THE UNITS IN THIS BATCH HAVE ALL BEEN QUARANTINED PENDING YOUR INSTRUCTIONS. ANOTHER BATCH ALREADY IN STOCK HAS BEEN SUPPLIED TO USERS. WE LOOK FORWARD TO HEARING FROM YOU REGARDING THE FOLLOW-UP TO THIS MATERIOVIGILANCE ISSUE AND WILL BE HAPPY TO PROVIDE ANY FURTHER INFORMATION YOU MAY REQUIRE. ADDITIONAL INFORMATION RECEIVED ON 27-DEC-2024. COULD YOU PROVIDE US WITH THE DATES OF THE EVENTS ON THE TWO OCCASIONS THAT OCCURRED? THE DATE OF THE FIRST EVENT IS NOT KNOWN. THE SECOND EVENT OCCURRED ON (B)(6)2024. - PLEASE CONFIRM IF 2 PATIENTS OR USERS WERE HARMED ON 2 OCCASIONS? IF YES, PLEASE EXPLAIN PATIENTS WERE NOT HARMED: NO INJECTIONS PERFORMED. - WE ARE AWARE THAT SAMPLES ARE AVAILABLE FOR INVESTIGATION. COULD YOU PLEASE SPECIFY IF THESE SAMPLES ARE UNUSED (BEFORE USE). USED (DURING OR AFTER USE) THE FAULTY CANULA FROM THE SECOND EVENT IS AVAILABLE FOR INVESTIGATION. IT WAS PUT ON THE SYRINGE PRE-FILLED WITH PRODUCT AND PURGED AFTERWARDS, BUT NO INJECTION WAS MADE. IMPORTANT: IF USED, PLEASE CONFIRM WHETHER THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC DRUGS. NO USE IN THE PATIENT, THEREFORE NO CONTAMINATION WITH BLOOD OR CYTOTOXIC PRODUCTS.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1987433 | BD CONVENTIONAL NEEDLES | NEEDLES, HYPODERMIC | FMI | BECTON DICKINSON, S.A. | 240701 | 00382903040001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |