SYRINGE 30ML LL S/C 56
Report
- Report Number
- 1911916-2023-00901
- Event Type
- Malfunction
- Date Received
- December 18, 2023
- Date of Event
- November 27, 2023
- Report Date
- March 5, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- UDI-DI
- 30382903028321
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PR (B)(4) FOLLOW UP. IT WAS REPORTED THERE WAS A GRAY FOREIGN MATERIAL ON LUER BODY. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING BLISTER AND SOME SOLUTION. THERE IS ALSO FOREIGN MATTER. FROM THE PHOTO IT IS NOT POSSIBLE TO CONFIRM IF THE FOREIGN MATTER IS LOOSE OR EMBEDDED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 3132083. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE ACTUAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION.
PR 9309614 FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE WAS A GRAY FOREIGN MATERIAL ON LUER BODY. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE IS A FOREIGN MATTER AT THE BOTTOM OF THE SYRINGE BARREL. IT IS POSSIBLE TO MOVE THE FOREIGN MATTER WHEN THE PLUNGER ROD-RUBBER STOPPER IS MOVED WHICH CONFIRMS IT IS NOT EMBEDDED. THE FOREIGN MATTER APPEARS TO BE LUBRICANT APPLIED TO THE SYRINGE BARREL INNER WALL AND RUBBER STOPPER. SINCE THE SAMPLE HAD BEEN CONTAMINATED WITH A CHEMOTHERAPY DRUG, NO ADDITIONAL ANALYSIS WAS PERFORMED. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING BLISTER AND SOME SOLUTION. THERE IS ALSO FOREIGN MATTER. FROM THE PHOTO IT IS NOT POSSIBLE TO CONFIRM IF THE FOREIGN MATTER IS LOOSE OR EMBEDDED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 3132083. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.
(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.
NOT AVAILABLE. A GRAY FOREIGN MATERIAL ON LUER BODY.
NO ADDITIONAL INFORMATION RECEIVED NOT AVAILABLE A GRAY FOREIGN MATERIAL ON LUER BODY
NOT AVAILABLE. A GRAY FOREIGN MATERIAL ON LUER BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58525 | SYRINGE 30ML LL S/C 56 | SYRINGE, PISTON | FMF | BECTON DICKINSON | 3132083 | 30382903028321 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |