BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 13619375 · Received February 28, 2022

    Report

    Report Number
    3002682307-2022-00067
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    January 26, 2022
    Report Date
    April 13, 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

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 28-MAR-2022. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309110 AND LOT NUMBER 2110221. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, LEAKAGE COULD BE OBSERVED. IT HAS BEEN DETERMINED THAT THE LEAKAGE MOST LIKELY RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY OCCUR DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE LEAKED WHILE SAMPLING THE SALINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "... THE SYRINGE WAS LEAKING WITHOUT THIS PROBLEM BEING DETECTED WHEN THE 0.9% NACL WAS SAMPLED... THE LEAK PROBLEM SEEMS RECURRENT DURING SAMPLING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE LEAKED WHILE SAMPLING THE SALINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "... THE SYRINGE WAS LEAKING WITHOUT THIS PROBLEM BEING DETECTED WHEN THE 0.9% NACL WAS SAMPLED... THE LEAK PROBLEM SEEMS RECURRENT DURING SAMPLING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685610 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110221

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown