BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP
Report
- Report Number
- 3003152976-2022-00088
- Event Type
- Malfunction
- Date Received
- March 4, 2022
- Date of Event
- February 18, 2022
- Report Date
- August 8, 2022
- 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
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.
H.6. INVESTIGATION: SEVERAL PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A PARTICLE CAN BE OBSERVED BETWEEN THE STOPPER AND SYRINGE BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2111034, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO FOREIGN MATTER OR OTHER PARTICLES WERE OBSERVED WITHIN ANY OF THE SYRINGES. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER AND VACUUM SYSTEM USED TO REMOVE ANY PARTICLES INSIDE THE BARREL. 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. WITHOUT THE PHYSICAL SAMPLE TO EVALUATE, THE ORIGIN OF THE PARTICLE CANNOT BE IDENTIFIED. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THE PARTICLE LIKELY GENERATED DURING THE ASSEMBLY PROCESS DUE TO FRICTION DURING MOVEMENT OF THE DEVICE WITHIN THE MANUFACTURING EQUIPMENT.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL: YES . D.10. RETURNED TO MANUFACTURER ON: 09-AUG-2022. H.6. INVESTIGATION SUMMARY: ONE SAMPLE ALONG WITH SEVERAL PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A PARTICLE CAN BE OBSERVED BETWEEN THE STOPPER AND SYRINGE BARREL. FURTHER EVALUATION IDENTIFIED THE PARTICLE TO BE A MIXTURE OF DIRT AND POLYPROPYLENE PARTICLES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2111034, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO FOREIGN MATTER OR OTHER PARTICLES WERE OBSERVED WITHIN ANY OF THE SYRINGES. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER AND VACUUM SYSTEM USED TO REMOVE ANY PARTICLES INSIDE THE BARREL. 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. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THE PARTICLE LIKELY GENERATED DURING THE ASSEMBLY PROCESS DUE TO FRICTION DURING MOVEMENT OF THE DEVICE WITHIN THE MANUFACTURING EQUIPMENT. A PROJECT WAS INITIATED TO REDUCE ANY FOREIGN PARTICLES INSIDE OUR PRODUCTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.
IT WAS REPORTED BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP HAD FOREIGN MATTER ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRESENCE OF PARTICLES IN THE PLUNGER SEAL"
IT WAS REPORTED BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP HAD FOREIGN MATTER ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRESENCE OF PARTICLES IN THE PLUNGER SEAL".
IT WAS REPORTED BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP HAD FOREIGN MATTER ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRESENCE OF PARTICLES IN THE PLUNGER SEAL".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1629382 | BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2111034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |