BD SYRINGE 1ML LL BNS
Report
- Report Number
- 1213809-2024-01050
- Event Type
- Malfunction
- Date Received
- January 13, 2025
- Date of Event
- December 20, 2024
- Report Date
- February 27, 2025
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 50382903096485
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
TWO PHOTOS OF 1 ML LL SYRINGES (P/N 309648) WERE RECEIVED AND EVALUATED. THE FIRST PHOTO SHOWS TWO LOOSE SAMPLES HELD BY SOMEONE'S FINGERS WITH GLOVES ON. THE BOTTOM SYRINGE APPEARS TO HAVE A SMEAR ON THE 0.7 MINOR GRAD LINES, WHILE THE TOP SYRINGE SEEMS TO HAVE A CRACKED BARREL, THOUGH THIS IS UNCLEAR FROM THE PHOTO. THE SECOND PHOTO DISPLAYS THREE LOOSE SYRINGES; THE FIRST TWO SYRINGES APPEAR TO HAVE CRACKS EXTENDING FROM THE 0.9 MARK DOWNWARD, AND THE THIRD SYRINGE SHOWS A LARGE SMEAR, AFFECTING A SIGNIFICANT SECTION OF THE NON-SCALE MARKING AREA. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE POTENTIAL ROOT CAUSE FOR THE SMEARED PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. A PHYSICAL SAMPLE IS REQUIRED FOR A THOROUGH EVALUATION AND ROOT CAUSE DETERMINATION FOR CRACKED BARRELS AND MISSING PLUNGER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT THE BD SYRINGE 1ML LL BNS HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BAD PRINT - MISSING PLUNGER'S MAT. 309648 - 309628 / BATCH: 4243174 / (B)(4). DURING USE. DURING UNPACKING OF MAT. 309648 - 309628 / BATCH: 4243174 (SYRINGE, LL, 3 PART, 1CC (EXT) PALLET NR. 1004532074), WE NOTICED THAT SOME OF THE SYRINGES HAD POOR PRINTING. OTHER SYRINGES WERE MISSING PLUNGERS AND WERE CONSIDERED DEFECTIVE. PLEASE INVESTIGATE WHY THIS ISSUE OCCURRED IN THE ABOVE BATCH AND PLEASE PROVIDE US WITH CORRECTIVE ACTIONS. THANK YOU FOR YOUR SUPPORT AND PLEASE REACH OUT IF YOU NEED MORE INFORMATION. ADDITIONAL INFORMATION PROVIDED: COULD YOU PLEASE PROVIDE A DATE OF EVENT? DECEMBER 18TH 2024. COULD YOU PLEASE CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE SPECIFY IF THE SAMPLES ARE: NO. UNUSED (BEFORE USE). USED (DURING OR AFTER USE). IMPORTANT: IF USED, PLEASE CONFIRM IF THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC MEDICATION. IF YOU HAVE RETAINED A SAMPLE FOR INVESTIGATION, PLEASE PROVIDE US WITH THE PICK-UP ADDRESS (FULL DETAILS ¿ PLEASE USE THE TEMPLATE BELOW). TO ENSURE SMOOTH COLLECTION, WE HIGHLY RECOMMEND INDICATING AN EASILY ACCESSIBLE LOCATION, SUCH AS HOSPITAL PHARMACY, YOUR GOODS-IN/OUT DEPARTMENT, MAILING ROOM, OR MAIN RECEPTION. THE ADDRESS SHOULD NOT BE INSIDE THE HOSPITAL UNIT (MATERNITY, ONCOLOGY, ETC.). AN EMPTY REGULATED SHIPPING BOX, ALONG WITH NECESSARY ACCESSORIES, WILL BE DELIVERED TO THE SAME ADDRESS. WE WILL ARRANGE SAMPLE COLLECTION BY OUR CARRIER. IF IT IS NOT POSSIBLE TO RETURN A PHYSICAL SAMPLE, COULD YOU PLEASE SUPPORT THE INVESTIGATION BY PROVIDING DETAILED PHOTOGRAPHS OF THE AFFECTED PRODUCT?
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1987493 | BD SYRINGE 1ML LL BNS | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 4243174 | 50382903096485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |