BD EMERALD - 3-PIECE SYRINGE
Report
- Report Number
- 3002682307-2023-00136
- Event Type
- Malfunction
- Date Received
- May 24, 2023
- Date of Event
- May 3, 2023
- Report Date
- October 4, 2023
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- K113241
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2205131. MEDICAL DEVICE EXPIRATION DATE: 30APR2027. DEVICE MANUFACTURE DATE: 29APR2022. MEDICAL DEVICE LOT #: 2212139. MEDICAL DEVICE EXPIRATION DATE: 30NOV2027. DEVICE MANUFACTURE DATE: 05DEC2022.
H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 307731 AND LOT NUMBER 2212139. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY. HOWEVER, THE RETAINED SAMPLES DID NOT DISPLAY ANY SIGNS OF PACKAGING DEFECT. IT IS POSSIBLE THAT THE REPORTED INCIDENT RESULTED FROM A NON-EXISTENT PERFORATION CUT IN THE UNIT PACKAGES, BUT THE CUT IS CLEARLY SEEN ON ALL OF THE BLISTER PACKAGES RETAINED FOR TESTING. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.
H6: INVESTIGATION SUMMARY AS NEITHER A LOT NUMBER NOR A SAMPLE WAS AVAILABLE FOR THIS INCIDENT, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, AN EXACT MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4 DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT THE BD EMERALD - 3-PIECE SYRINGE EXPERIENCED POOR PERFORATION ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN SEPARATING THE UNITS IT BREAKS TOO EASILY AND SOME UNITS MAY BE LEFT WITH BROKEN WRAPPING (AND STERILITY LOST).
IT WAS REPORTED THAT THE BD EMERALD - 3-PIECE SYRINGE EXPERIENCED POOR PERFORATION ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN SEPARATING THE UNITS IT BREAKS TOO EASILY AND SOME UNITS MAY BE LEFT WITH BROKEN WRAPPING (AND STERILITY LOST).
IT WAS REPORTED THAT THE BD EMERALD - 3-PIECE SYRINGE EXPERIENCED POOR PERFORATION ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN SEPARATING THE UNITS IT BREAKS TOO EASILY AND SOME UNITS MAY BE LEFT WITH BROKEN WRAPPING (AND STERILITY LOST).
IT WAS REPORTED THAT THE BD EMERALD - 3-PIECE SYRINGE EXPERIENCED POOR PERFORATION ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN SEPARATING THE UNITS IT BREAKS TOO EASILY AND SOME UNITS MAY BE LEFT WITH BROKEN WRAPPING (AND STERILITY LOST).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1897195 | BD EMERALD - 3-PIECE SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |