BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABG SYRINGE, 3 ML ALINE

    MDR report key: 7077347 · Received December 1, 2017

    Report

    Report Number
    9617032-2017-00276
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    February 22, 2016
    Report Date
    November 3, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: SIX PHOTOGRAPHS AND SAMPLES WERE RETURNED TO BD FOR EVALUATION. 100 POUCHES WERE RETURNED AND 28 OF THEM WERE NOT SEALED LONGITUDINALLY. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5202031. CONCLUSION: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. AN ERROR OCCURED WHEN THE FIN SEAL WAS BEING CREATED WHICH MEANT THE POUCH REMAINED UNSEALED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABG SYRINGE 3 ML ALINE PACKAGING WAS NOT SEALED, RESULTING IN A STERILE BREACH. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853327 ABG SYRINGE, 3 ML ALINE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5202031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other