BD DISCARDIT¿ II - 2-PIECE SYRINGE
Report
- Report Number
- 3002682307-2022-00040
- Event Type
- Malfunction
- Date Received
- February 3, 2022
- Date of Event
- January 20, 2022
- Report Date
- May 16, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2005245. MEDICAL DEVICE EXPIRATION DATE: 04/30/2025. DEVICE MANUFACTURE DATE: 05/20/2020. MEDICAL DEVICE LOT #: 2101101. MEDICAL DEVICE EXPIRATION DATE: 12/31/2025. DEVICE MANUFACTURE DATE: 12/29/2020. MEDICAL DEVICE LOT #: 2101228. MEDICAL DEVICE EXPIRATION DATE: 12/31/2025. DEVICE MANUFACTURE DATE: 01/20/2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2005245. MEDICAL DEVICE EXPIRATION DATE: 04/30/2025. DEVICE MANUFACTURE DATE: 05/20/2020. MEDICAL DEVICE LOT #: 2101101. MEDICAL DEVICE EXPIRATION DATE: 12/31/2025. DEVICE MANUFACTURE DATE: 12/29/2020. MEDICAL DEVICE LOT #: 2101228. MEDICAL DEVICE EXPIRATION DATE: 12/31/2025. DEVICE MANUFACTURE DATE: 01/20/2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309050 AND LOT NUMBERS 2005245, 2101101, AND 2101228. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, WHITE PARTICLES WERE OBSERVED WITHIN THE SYRINGES. WE HAVE CONCLUDED THAT THE PARTICLES ARE COMPOSED OF THE SLIP AGENT USED IN THE MANUFACTURE OF THIS SYRINGE PRODUCT. THIS SLIP AGENT IS USED TO FACILITATE THE MOVEMENT OF THE PLUNGER ALONG THE BARREL. DURING THE MANUFACTURING PROCESS, THE LUBRICANT FORMS A MICROSCOPIC LAYER IN THE INTERNAL/EXTERNAL WALLS OF THE BARREL. WHEN THE PLUNGER IS MOVED BACKWARDS DURING THE FILLING OF THE SYRINGE, MOST OF THIS MICROSCOPIC LAYER OF LUBRICANT IS DRAGGED BEHIND THE PLUNGER AND A SMALL QUANTITY STILL REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION OPERATION. THIS IS A NORMAL PROCESS AND THE SYRINGE WOULD NOT WORK WITHOUT THE PRESENCE OF THIS LUBRICANT.
IT WAS REPORTED 5 BD DISCARDIT¿ II - 2-PIECE SYRINGES HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LINT WAS FOUND INSIDE THE SYRINGE".
IT WAS REPORTED 5 BD DISCARDIT¿ II - 2-PIECE SYRINGES HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LINT WAS FOUND INSIDE THE SYRINGE".
IT WAS REPORTED 5 BD DISCARDIT¿ II - 2-PIECE SYRINGES HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LINT WAS FOUND INSIDE THE SYRINGE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1812339 | BD DISCARDIT¿ II - 2-PIECE SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | SEE H.10. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |