BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 11518130 · Received March 18, 2021

    Report

    Report Number
    3002682307-2021-00097
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 15, 2021
    Report Date
    May 3, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2011154. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE ORIGINALLY FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD. THROUGH MAGNIFIED INSPECTION, DAMAGE WAS OBSERVED TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE CAN BE PRODUCED 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 PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "LACK OF TIGHTNESS AT THE PISTON LEVEL, THE LIQUID LEAKS ALONG. CLINICAL CONSEQUENCE: NONE THIS INCIDENT TOOK PLACE IN HEMATOLOGY ON (B)(6) 2021."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE BD DISCARDIT" II SYRINGE LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "LACK OF TIGHTNESS AT THE PISTON LEVEL, THE LIQUID LEAKS ALONG. CLINICAL CONSEQUENCE: NONE. THIS INCIDENT TOOK PLACE IN HEMATOLOGY ON (B)(6) 2021."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411124 BD DISCARDIT II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2011154

    Patients

    Seq Age Sex Outcome Treatment
    1