BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE¿ WITH NEEDLE

    MDR report key: 16152849 · Received January 12, 2023

    Report

    Report Number
    3002682307-2022-00370
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 21, 2022
    Report Date
    February 13, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    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 LIP COMPONENT, RESULTING IN A 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 IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE¿ WITH NEEDLE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "LEAKAGE FOUND DURING DISPENSING".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE¿ WITH NEEDLE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "LEAKAGE FOUND DURING DISPENSING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964075 BD SYRINGE¿ WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1901125

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown