BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
Report
- Report Number
- 3003152976-2023-00182
- Event Type
- Malfunction
- Date Received
- May 18, 2023
- Date of Event
- April 20, 2023
- Report Date
- August 9, 2023
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED NACL PAST THE PLUNGER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS.
H6: INVESTIGATION SUMMARY: ONE PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL EVALUATION, LEAKAGE PAST STOPPER IS OBSERVED. BARREL DOES NOT PRESENT ANY DAMAGE THAT COULD HAVE DEFORMED THEIR SHAPE, THE STOPPER IS CORRECTLY ASSEMBLED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2301010, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.
IT WAS REPORTED THAT 4 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED PAST THE PLUNGER, WITH 2 SYRINGES HAVING LEAKED NAL, 1 HAVING LEAKED EPIRUBICIN, AND 1 HAVING LEAKED OXALIPLATIN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DURING A PREPARATION OF A CHEMOTHERAPY BAG, LEAKAGE OF LIQUID THROUGH THE PLUNGER OF THE SYRINGE: EXPOSURE OF THE STAFF TO ANTICANCER DRUGS BECAUSE LIQUID LEAKED OUT OF THE SYRINGE, NEED TO DECONTAMINATE THE WORK SURFACE. LOSS OF TIME, STRESS. THIS PROBLEM HAPPENED TWICE THIS MORNING WITH THIS BATCH, I DON'T KNOW IF IT ONLY CONCERNS A FEW UNITS. I INSIST BECAUSE THE INCIDENT HAPPENED AGAIN WITH OXALIPLATIN (SYRINGE PUT ASIDE), IN THE MEANTIME WE DO NOT USE ANY MORE 50 ML SYRINGES TO WITHDRAW ANTICANCER DRUGS... A 3RD CASE THIS MORNING WITH NACL. 4 INCIDENTS YESTERDAY INCLUDING 2 INCIDENTS WITH NAL, 1 WITH EPIRUBICIN AND 1 WITH OXALIPLATIN (WE KEPT 3 SYRINGES OUT OF 4) AND 1 INCIDENT THIS MORNING WITH PACLITAXEL (SYRINGE THROWN AWAY)."
IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED NACL PAST THE PLUNGER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DURING A PREPARATION OF A CHEMOTHERAPY BAG, LEAKAGE OF LIQUID THROUGH THE PLUNGER OF THE SYRINGE: EXPOSURE OF THE STAFF TO ANTICANCER DRUGS BECAUSE LIQUID LEAKED OUT OF THE SYRINGE, NEED TO DECONTAMINATE THE WORK SURFACE. LOSS OF TIME, STRESS. THIS PROBLEM HAPPENED TWICE THIS MORNING WITH THIS BATCH, I DON'T KNOW IF IT ONLY CONCERNS A FEW UNITS... I INSIST BECAUSE THE INCIDENT HAPPENED AGAIN WITH OXALIPLATIN (SYRINGE PUT ASIDE), IN THE MEANTIME WE DO NOT USE ANY MORE 50 ML SYRINGES TO WITHDRAW ANTICANCER DRUGS... A 3RD CASE THIS MORNING WITH NACL... 4 INCIDENTS YESTERDAY INCLUDING 2 INCIDENTS WITH NAL, 1 WITH EPIRUBICIN AND 1 WITH OXALIPLATIN (WE KEPT 3 SYRINGES OUT OF 4) AND 1 INCIDENT THIS MORNING WITH PACLITAXEL (SYRINGE THROWN AWAY)."
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED NACL PAST THE PLUNGER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1893803 | BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2301010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |