BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE SYRINGE INJECTOR WITHOUT RUBBER STOPPER

    MDR report key: 16218438 · Received January 20, 2023

    Report

    Report Number
    3002682307-2022-00372
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    December 23, 2022
    Report Date
    February 13, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903019403
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301940 AND LOT NUMBER 1901125. 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 RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. HOWEVER, THE RETAINED SAMPLES DID NOT DISPLAY ANY SIGNS OF DEFECT. BASED ON THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT THE REPORTED INCIDENT WAS CAUSED BY DAMAGE TO THE PLUNGER COMPONENT, RESULTING IN LEAKAGE. THIS TYPE OF DAMAGE MAY BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE.

    Additional Manufacturer Narrative · 0

    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 SYRINGE SYRINGE INJECTOR WITHOUT RUBBER STOPPER LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: LEAKAGE FOUND DURING DISPENSING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE INJECTOR WITHOUT RUBBER STOPPER LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: LEAKAGE FOUND DURING DISPENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871291 BD SYRINGE SYRINGE INJECTOR WITHOUT RUBBER STOPPER PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1901125 00382903019403

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown