BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 12407237 · Received September 1, 2021

    Report

    Report Number
    3002682307-2021-00454
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    June 10, 2021
    Report Date
    August 30, 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 · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2103218. 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. 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 IDENTIFIED TO THE PLUNGER ROD LIP COMPONENT. DAMAGE TO THE PLUNGER LIP COMPONENT CAN RESULT DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING FACILITY OR DURING THE ASSEMBLY PROCESS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. HOWEVER, A QUALITY PROCESS HAS BEEN INITIATED WITH THE AIM OF REDUCING THIS TYPE OF DEFECT. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE PLUNGER ROD WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "PREPARATION OF AN INFUSION. AIR ENTERS THE SYRINGE THROUGH THE PLUNGER." VIA BD INVESTIGATION: "THROUGH EXAMINATION OF THE SAMPLE, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD. THROUGH MAGNIFIED INSPECTION, DAMAGE WAS IDENTIFIED TO THE PLUNGER ROD LIP COMPONENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302105 BD DISCARDIT II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2103218

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR