BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES NON-STERILE

    MDR report key: 16620313 · Received March 27, 2023

    Report

    Report Number
    3003152976-2023-00100
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    March 7, 2023
    Report Date
    May 9, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 27-MAR-2023. TEN SAMPLES RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, WHITE SMALL PARTICLES CAN BE OBSERVED DISTRIBUTED IN THE FLUID PATH OF THE SYRINGE. FURTHER TESTING WAS PERFORMED, THE PARTICLE WAS IDENTIFIED TO BE A POLYPROPYLENE PARTICLE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2302101 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. 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. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT AND REDUCE PARTICLES FROM GENERATING. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES NON-STERILE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AGAIN, ON THE INSIDE/OUTSIDE AND ON THE PLUNGER ARE LOOSE WHITE PARTICLES. WHEN TOUCHED THESE PARTICLES MOVE. THE SYRINGES ARE NOT FIT FOR PURPOSE. THE PRODUCT WE SUPPLY TO THE NHS REQUIRES TO BE ¿PARTICLE FREE¿. 2302101 ¿ QUANTITY 8,400 REJECTED. 2209075 QUANTITY 4, 462 REJECTED. 2212037 QUANTITY 8,400 REJECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES NON-STERILE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AGAIN, ON THE INSIDE/OUTSIDE AND ON THE PLUNGER ARE LOOSE WHITE PARTICLES. WHEN TOUCHED THESE PARTICLES MOVE. THE SYRINGES ARE NOT FIT FOR PURPOSE. THE PRODUCT WE SUPPLY TO THE NHS REQUIRES TO BE ¿PARTICLE FREE¿. 2302101, QUANTITY: 8,400, REJECTED, 2209075, QUANTITY: 4, 462, REJECTED, 2212037, QUANTITY: 8,400, REJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739922 BD PLASTIPAK¿ SYRINGES NON-STERILE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2302101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown