SYRINGE 20ML LL S/C 50
Report
- Report Number
- 9614033-2024-00023
- Event Type
- Malfunction
- Date Received
- March 6, 2024
- Date of Event
- February 26, 2024
- Report Date
- May 10, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- UDI-DI
- 00382903033102
- PMA / PMN Number
- K151766
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
(B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
PHOTOS RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT CAN BE OBSERVED THAT THE SYRINGE IS LUBRICATED WITHIN THE FLUID PATH. UNABLE TO IDENTIFY THE FOREIGN MATTER WITHOUT PHYSICAL SAMPLES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 3012142 , 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. BASED ON THE TEAMS INVESTIGATION, POSSIBLE ROOT CAUSE IS ASSOCIATED WITH SILICONE INJECTION SYSTEM. MAINTENANCE PLAN 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.
MATERIAL #: 303310, BATCH#: 3012142. IT WAS REPORTED BY CUSTOMER THAT I HAVE A CONCERN REGARDING BD 20ML SYRINGE - LUER-LOCK TIP, REF: (B)(4). MY TECHNICIAN AND I NOTICED THAT SOME OF THE SYRINGES LOOKED MORE "OILY" THAN OTHER SYRINGES, ABOVE AND BELOW THE PLUNGER TIP. IS THIS SOMETHING WE SHOULD BE CONCERNED ABOUT OR IS THIS NORMAL? MY TECHNICIAN NOTIFIED ME THAT SHE NOTICED AT LEAST 8-10 SYRINGES THAT APPEARED LIKE THIS WHEN COMPOUNDING TODAY. PICTURE 1 SHOWS AN "OILY" SYRINGE AND PICTURE 2 SHOWS A NORMAL SYRINGE. THANK YOU FOR YOUR TIME. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. MY NAME IS (B)(6) AND I AM A PHARMACIST AT (B)(6) MEDICAL CENTER. I HAVE A CONCERN REGARDING BD 20ML SYRINGE - LUER-LOCK TIP, REF: (B)(4). MY TECHNICIAN AND I NOTICED THAT SOME OF THE SYRINGES LOOKED MORE "OILY" THAN OTHER SYRINGES, ABOVE AND BELOW THE PLUNGER TIP. IS THIS SOMETHING WE SHOULD BE CONCERNED ABOUT OR IS THIS NORMAL? MY TECHNICIAN NOTIFIED ME THAT SHE NOTICED AT LEAST 8-10 SYRINGES THAT APPEARED LIKE THIS WHEN COMPOUNDING TODAY. PICTURE 1 SHOWS AN "OILY" SYRINGE AND PICTURE 2 SHOWS A NORMAL SYRINGE. THANK YOU FOR YOUR TIME. ITEM: BD 20ML SYRINGE LUER-LOCK TIP, REF: (B)(4). LOT:3012142. EXP: 01/31/28. HI, HERE ARE THE ANSWERS TO THE QUESTIONS: WHERE WAS THE FM LOCATED? IN THE FLUID PATH? INSIDE OR OUTSIDE PACKAGING? THE LIQUID WAS LOCATED ALONG THE WALLS OF THE BARREL AND GLOBS WERE VISIBLE ON THE PLUNGER. WE DID NOT NOTICE ANYTHING INSIDE OR OUTSIDE THE PACKAGING. WHEN DID THE INCIDENT OCCUR? MY TECH NOTICED THIS LAST WEEK, BUT THEY WERE ONLY 1 OR 2 SYRINGES. SHE THOUGHT MAYBE IT WAS A ONE OFF. BUT ON (B)(6) 2024 SHE NOTICED AT LEAST 8-10 SYRINGES THAT WERE LIKE PICTURE #1 DATE OF EVENT: 2/26/24. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES - (B)(6).
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1538865 | SYRINGE 20ML LL S/C 50 | SYRINGE, PISTON | FMF | BECTON DICKINSON | 3012142 | 00382903033102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |