BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

    MDR report key: 12865158 · Received November 23, 2021

    Report

    Report Number
    9614033-2021-00140
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 26, 2021
    Report Date
    December 13, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION AN ASSEMBLED NEEDLE WITH A LACK OF COMPONENT (SHIELD) WHICH COMES OUT OF THE BLISTER IN ITS UPPER PART, THAT IS, THROUGH THE PART OF THE FLANGE ON ONE SIDE OF THE PLUNGER IS OBSERVED. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH LACK OF GUARD IN THE NEEDLE FEEDER. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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 NEEDLE CAP WAS MISSING WITH A BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: DURING THE INSPECTION UPON RECEIPT, ONE NEEDLE WITHOUT A CAP (EXPOSED).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE CAP WAS MISSING WITH A BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: DURING THE INSPECTION UPON RECEIPT, ONE NEEDLE WITHOUT A CAP (EXPOSED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760955 BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 1197372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown