BD LUER-LOK
Report
- Report Number
- 1213809-2024-00949
- Event Type
- Malfunction
- Date Received
- December 12, 2024
- Date of Event
- October 28, 2024
- Report Date
- January 30, 2025
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096573
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.4. OTHER LOT NUMBER INCLUDES 4075159 AND OTHER EXPIRATION DATE INCLUDES 2029-02-28. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2024-03-15.
TWO SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. BOTH SYRINGES WERE RECEIVED IN SEALED PACKAGE ONE FROM BATCH 4075159, AND ONE FROM BATCH 4123700, WITH BOTH HAVING ALL SCALE MARKINGS PRESENT AND ACCEPTABLE. BOTH SYRINGES WERE TESTED FOR INK PERMANENCY AND FOUND TO BE ACCEPTABLE WITH NO SCALE MARKINGS BEING REMOVED DURING TESTING. ONE PHOTO SHOW FOUR LOOSE SYRINGES CONSISTING OF TWO 3ML SYRINGES, ONE 10ML SYRINGE, AND ONE 5ML SYRINGE WITH EACH HAVING A PORTION OR ALL THE SCALE MARKINGS FADED OR MISSING. THE REPORTED DEFECT WAS NOT OBSERVED IN THE SAMPLE TESTED FROM THE SEALED PACKAGE AND THE CONDITION OBSERVED FROM THE PHOTO PROVIDED CANNOT BE CONFIRMED TO HAVE ORIGINATED AT THE MANUFACTURING PLANT. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 4075159 AND 4123700. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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 LUER-LOK HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THERE HAS BEEN A REPORTED ISSUE WITH THE INK FROM OUR LUER-LOK SYRINGES WEARING OFF. WE HAVE TESTED SEVERAL AND SOME APPEAR TO WEAR OFF FROM HANDLING, BODY HEAT. IT APPEARS TO EFFECT MULTIPLE SIZES. ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 10-28-24. 3. PROVIDED ONLY THE 5ML SYRINGE MATERIAL NUMBER & LOT NUMBER , WE NEED THE MATERIAL AND LOT NUMBER OF ALL TYPE SYRINGES WHICH HAVING SYRINGE MARKING ISSUE? THE ONLY OTHER LOT I HAVE IS WITH THE 3ML LL, 4142406. 4. TOTAL NUMBER INDIVIDUAL OCCURRENCES OF SYRINGE? FIVE THAT HAVE BEEN REPORTED TO ME. 5. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL?
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1894230 | BD LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 4123700 | 30382903096573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |