BD CONVENTIONAL NEEDLES
Report
- Report Number
- 3002682307-2024-00257
- Event Type
- Malfunction
- Date Received
- December 26, 2024
- Date of Event
- August 30, 2024
- Report Date
- January 17, 2025
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- UDI-DI
- 00382903046225
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304622 AND LOT NUMBER 221104. 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, A PICTURE OF THE NEEDLE PRODUCT¿S SHELF CARTON LABEL WAS PROVIDED AND PHYSICAL SYRINGE SAMPLES WERE RETURNED (INVESTIGATED UNDER PR11259607). THROUGH EVALUATION OF THE SAMPLES, A DEFECT RELATED TO THE NEEDLE PRODUCT COULD NOT BE IDENTIFIED. REGRETTABLY, WITH THE INFORMATION PROVIDED, WE WERE UNABLE TO DETERMINE A CAUSE RELATED TO THE MANUFACTURING PROCESS FOR THIS INCIDENT. IF ALL AFFECTED MATERIALS BECOME AVAILABLE, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. PER THE PROVIDED FEEDBACK OF ¿THE PARTICULATE IS WHITE AND THUS MOST CLOSELY ALIGNS WITH THE ADHESIVE¿¿ WE WOULD LIKE TO INFORM YOU THAT DURING THE ASSEMBLY PROCESS, THE EPOXY (ADHESIVE USED TO JOIN THE CANNULA AND HUB COMPONENTS) IS CURED IN AN OVEN. AFTER THIS CURING PROCESS, IT IS PRACTICALLY IMPOSSIBLE FOR THE EPOXY TO GENERATE ANY FOREIGN PARTICLES THAT WOULD END UP IN THE FLUID PATHWAY. 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.
IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR CLINICAL SITE FOUND WHITE PARTICLES FLOATING IN THE DRUG PRODUCT AFTER WITHDRAWING THE DRUG PRODUCT FROM A VIAL WITH BD LUER LOCK SYRINGE AND MICROLANCE 3 NEEDLE. THERE WERE 6 OBSERVATIONS OF PARTICLES IN SYRINGES. THIS PARTICULATE IS NOT DRUG OR CONTAINER (VIAL + STOPPER) RELATED. IT MAY BE PART FOR THE NEEDLE/SYRINGE SYSTEM USED FOR DRUG EXTRACTION FROM THE VIAL. THE PARTICULATE IS WHITE AND THUS MOST CLOSELY ALIGNS WITH THE ADHESIVE USED BY BD TO BOND THE NEEDLE TO THE NEEDLE HUB OF THE BD MICROLANCE NEEDLE. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE. PARTICLES IN SYRINGE DETECTED BEFORE ADMINISTRATION TO PATIENT. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 23-AUG-2024, 30-AUG-2024, 05-SEP-2024. 3. TOTAL NUMBER OF OCCURRENCES ONLY MATERIAL#: 304622? SIX SYRINGES CONTAINED WHITE PARTICLES. NOT ABLE TO DETERMINE WHICH NEEDLE WAS USED WITH EACH SYRINGE. 4. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? SIX SYRINGES WITHOUT THE NEEDLES ARE AVAILABLE. CAN BD ACCEPT SYRINGES FILLED WITH BIOLOGIC DRUG PRODUCT? PLEASE SEND RETURN LABEL TO (B)(6). 5. WHETHER WHITE PARTICLES FOUND IN FLUID PATH? YES. SIX SYRINGES EXHIBITED WHITE PARTICLES IN FLUID PATH.
NO ADDITIONAL INFORMATION
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1745577 | BD CONVENTIONAL NEEDLES | NEEDLES, HYPODERMIC | FMI | BECTON DICKINSON, S.A. | 221104 | 00382903046225 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |