BD LUER-LOK
Report
- Report Number
- 9614033-2024-00003
- Event Type
- Malfunction
- Date Received
- January 19, 2024
- Date of Event
- December 20, 2023
- Report Date
- April 1, 2024
- Manufacturer
- BECTON DICKINSON DE MEXICO
- Product Code
- FMF
- UDI-DI
- 00382903033102
- PMA / PMN Number
- K151766
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.4. OTHER LOT NUMBER INCLUDES 3012143 AND OTHER EXPIRATION DATE INCLUDES 2028-01-31. OTHER LOT NUMBER INCLUDES 3012142 AND OTHER EXPIRATION DATE INCLUDES 2028-01-31. OTHER LOT NUMBER INCLUDES 2098110 AND OTHER EXPIRATION DATE INCLUDES 2027-04-30. OTHER LOT NUMBER INCLUDES 9015947 AND OTHER EXPIRATION DATE INCLUDES 2024-01-31. OTHER LOT NUMBER INCLUDES 2098112 AND OTHER EXPIRATION DATE INCLUDES 2027-04-30. 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 2023-03-15. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2023-03-15. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2022-06-16. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2019-03-21. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2022-06-18.
SEVEN SAMPLES AND PHOTO RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT CAN BE OBSERVED THAT THE SYRINGE IS LUBRICATED WITH WHAT APPEARS TO BE SILICONE. TESTING WAS PERFORMED, RESULTS VERIFIED EXCESS AMOUNT OF SILICONE ON THREE SYRINGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR REPORTED LOTS AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS EXCESS SILICONE CAN OCCUR DUE TO A FAILURE IN THE SPRAYER THAT DOSES THE SILICONE INSIDE THE BARRELS. MAINTENANCE PLAN FOR SILICONE NOZZLES WILL BE UPDATED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES.
IT WAS REPORTED THAT THE BD LUER-LOK SYRINGES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOISTURE INSIDE OF THE 20ML SYRINGES (LAWSON# 319377) ACROSS MULTIPLE LOT NUMBERS. ALL 20ML SYRINGES FROM OSC RWC HAVE BEEN PULLED FROM THE PAR CART AND HELD IN THE SUPPLY CHAIN OFFICE." ITEM: 303310. HERE ARE THE LOT NUMBERS FOR THE AFFECTED 20ML SYRINGES. 3012143, 3012142, 2098110, 2669632, 2339636, 9015947, 2098112, 3272892, 2179663, 2298216. ADDITIONAL INFORMATION RECEIVED ON 01/12/24: 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. (B)(6) 2023. 2. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? ALL STOCK WAS PUT ON HOLD PENDING A CONFIRMATION THAT THIS DEVIATION IS NOT A HEALTH CONCERN. 3. ANY PHYSICAL SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? IF YOU NEED SAMPLES IT IS NEEDED.
NO ADDITIONAL INFORMATION RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2406974 | BD LUER-LOK | SYRINGE, PISTON | FMF | BECTON DICKINSON DE MEXICO | 2339636 | 00382903033102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |