SYRINGE 30ML LL S/C 56
Report
- Report Number
- 1911916-2024-00477
- Event Type
- Malfunction
- Date Received
- July 8, 2024
- Date of Event
- June 10, 2024
- Report Date
- July 24, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- 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
PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THERE ARE BLACK PARTICULATE'S FLOATING IN THE MEDICATION AND IT APPEARS THE INK DID NOT DRY FULLY AND ENDED UP LOOSE ON THE PACKAGING. TO AID IN THE INVESTIGATION ONE HUNDRED FORTY-FOUR SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. SIXTEEN SAMPLES WERE FROM LOT 4030300 AND ONE HUNDRED TWENTY-EIGHT SAMPLES WERE FROM 4080899. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. NO FOREIGN MATTER OF ANY KIND WAS FOUND. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOTS 4030300 AND 4080899. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 302832; BATCH #: 4030300, 4080899. IT WAS REPORTED BY THE CUSTOMER THAT WAS NOTED TO HAVE BLACK PARTICULATES FLOATING IN THE MEDICATION. IT APPEARS THAT SOME OF THE SYRINGES THE INK DID NOT DRY FULLY AND ENDED UP LOOSE ON THE PACKAGING. ALSO, THERE IS AN ILLUSTRATION THAT SHOWS THE PARTICULATES END UP INSIDE THE BARREL WITH THE MEDICATIONS. THEY DO HAVE ALL PRODUCT QUARANTINED AND MULTIPLE PICTURES SHOWING THE PARTICULATES IN THE SYRINGES WITH THE FLUID. VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED. WHEN USING THE SYRINGES TO COMPOUND MEDICATIONS IN THE HOOD - IT WAS NOTED TO HAVE BLACK PARTICULATES FLOATING IN THE MEDICATION. IT APPEARS THAT SOME OF THE SYRINGES THE INK DID NOT DRY FULLY AND ENDED UP LOOSE ON THE PACKAGING. ALSO, THERE IS AN ILLUSTRATION THAT SHOWS THE PARTICULATES END UP INSIDE THE BARREL WITH THE MEDICATIONS. I DO HAVE ALL PRODUCT QUARANTINED AND MULTIPLE PICTURES SHOWING THE PARTICULATES IN THE SYRINGES WITH THE FLUID.
MATERIAL #: 302832 BATCH #: 4030300, 4080899. IT WAS REPORTED BY THE CUSTOMER THAT WAS NOTED TO HAVE BLACK PARTICULATES FLOATING IN THE MEDICATION. IT APPEARS THAT SOME OF THE SYRINGES THE INK DID NOT DRY FULLY AND ENDED UP LOOSE ON THE PACKAGING. ALSO, THERE IS AN ILLUSTRATION THAT SHOWS THE PARTICULATES END UP INSIDE THE BARREL WITH THE MEDICATIONS. THEY DO HAVE ALL PRODUCT QUARANTINED AND MULTIPLE PICTURES SHOWING THE PARTICULATES IN THE SYRINGES WITH THE FLUID. VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED. WHEN USING THE SYRINGES TO COMPOUND MEDICATIONS IN THE HOOD - IT WAS NOTED TO HAVE BLACK PARTICULATES FLOATING IN THE MEDICATION. IT APPEARS THAT SOME OF THE SYRINGES THE INK DID NOT DRY FULLY AND ENDED UP LOOSE ON THE PACKAGING. ALSO, THERE IS AN ILLUSTRATION THAT SHOWS THE PARTICULATES END UP INSIDE THE BARREL WITH THE MEDICATIONS. I DO HAVE ALL PRODUCT QUARANTINED AND MULTIPLE PICTURES SHOWING THE PARTICULATES IN THE SYRINGES WITH THE FLUID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 980054 | SYRINGE 30ML LL S/C 56 | SYRINGE, PISTON | FMF | BECTON DICKINSON | 4080899 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |