BD SYRINGE 5ML LS EMERALD
Report
- Report Number
- 3002682307-2020-00362
- Event Type
- Malfunction
- Date Received
- November 24, 2020
- Date of Event
- October 29, 2020
- Report Date
- March 29, 2021
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2002140 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE NOT RETURNED FOR THIS ISSUE, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE INSPECTED AND NO SIGNS OF BROWN/BLACK TAPE OR ANY TYPE OF FOREIGN MATTER WERE IDENTIFIED. BASED ON THE PROVIDED CUSTOMER FEEDBACK, IT IS POSSIBLE THAT A PIECE OF TAPE WAS INTRODUCED DURING THE PACKAGING PROCESS; HOWEVER, BASED ON THE INVESTIGATION FINDINGS, THIS EXACT CAUSE COULD NOT BE CONFIRMED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/2/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2002140. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, FOREIGN MATTER WAS OBSERVED WITHIN THE BLISTER PACKAGING. THE FOREIGN MATERIAL WAS IDENTIFIED AS A PIECE OF PRODUCT PACKAGING. THE PRIMARY PACKAGING FOR THE EMERALD SYRINGES CONSISTS OF BOTH FILM AND PAPER WHICH ARE SEALED TOGETHER THROUGH USE OF PRESSURE AND TEMPERATURE. METAL CLIPS ARE USED TO MOVE THE BLISTER PACKAGING STRIPS THROUGH THE MANUFACTURING PROCESS, BY GRASPING THE OUTER PACKAGING. IT HAS BEEN DETERMINED THAT A PIECE OF THE PACKAGING REMAINED STUCK WITHIN THE METAL CLIP AND WENT UNDETECTED BY THE MACHINE OPERATOR. THIS PIECE OF PACKAGING MATERIAL WAS THEN RE-CIRCULATED WITHIN THE PACKAGING PROCESS AND ENDED UP WITHIN THE AFFECTED BLISTER PACKAGE. WE HAVE EVALUATED 20 RETAINED SAMPLES OF THE REPORTED LOT AND NO DEFECT WAS OBSERVED. NO BROWN/BLACK TAPE OR ANY KIND OF FOREIGN MATTER WAS FOUND. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED WITH A BD SYRINGE 5ML LS EMERALD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALTHOUGH THE STERILE PACKAGING OF THE SYRINGE WAS SEALED, IT CONTAINED SOME DIRTY BROWN/BLACK TAPE.
IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED WITH A BD SYRINGE 5ML LS EMERALD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALTHOUGH THE STERILE PACKAGING OF THE SYRINGE WAS SEALED, IT CONTAINED SOME DIRTY BROWN/BLACK TAPE.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED WITH A BD SYRINGE 5ML LS EMERALD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALTHOUGH THE STERILE PACKAGING OF THE SYRINGE WAS SEALED, IT CONTAINED SOME DIRTY BROWN/BLACK TAPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1362491 | BD SYRINGE 5ML LS EMERALD | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2002140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |