BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 2 PC 10ML DISCARDIT II SYRINGE W/O NEEDLE

    MDR report key: 9689953 · Received February 10, 2020

    Report

    Report Number
    3002682307-2020-00042
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 21, 2020
    Report Date
    March 10, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS BEEN PROVIDED WITH A SAMPLE FOR CATALOG 309110 LOT 1909226 TO INVESTIGATE FOR THIS RECORD. BD HAS CARRIED OUT A LEAKAGE TEST ON THE RETURNED SAMPLE AND DETERMINED THAT IT DID NOT REPRESENT THE REPORTED DEFECT. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS WELL. BD BELIEVES THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED BECAUSE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 2 PC 10ML DISCARDIT II¿ SYRINGE W/O NEEDLE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: VERBATIM: ¿LEAKAGE AT THE PLUNGER OF THE SYRINGE: LIQUID / RUNS THROUGH THE PLUNGER, IT CANNOT BE GUARANTEED IF THE PATIENT RECEIVED THE CORRECT AMOUNT OF MEDICATION. SAMPLES WERE SENT TO HEIDELBERG.¿

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE BD 2 PC 10ML DISCARDIT II¿ SYRINGE W/O NEEDLE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: VERBATIM: ¿LEAKAGE AT THE PLUNGER OF THE SYRINGE: LIQUID / RUNS THROUGH THE PLUNGER, IT CANNOT BE GUARANTEED IF THE PATIENT RECEIVED THE CORRECT AMOUNT OF MEDICATION. SAMPLES WERE SENT TO (B)(4).¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154173 BD 2 PC 10ML DISCARDIT II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1909226

    Patients

    Seq Age Sex Outcome Treatment
    1 Other