BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABG SYRINGE,1 ML LUER-LOK SYRINGE WITH NEEDLE. REGULAR PLUNGER STOPPER &TIP CAP.

    MDR report key: 7096515 · Received December 7, 2017

    Report

    Report Number
    9617032-2017-00480
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    February 1, 2017
    Report Date
    January 26, 2018
    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
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). BD RECEIVED 3 PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. BASED ON THE EVALUATION OF THE PHOTOS, BD OBSERVED A SMALL WHITE FOREIGN MATTER ON THE SIDE OF THE PLUNGER STOPPER. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTOGRAPHS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT 510K NUMBER. IT IS CORRECTED TO READ K022426.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ABG SYRINGE,1 ML LUER-LOK SYRINGE WITH NEEDLE. REGULAR PLUNGER STOPPER &TIP CAP WAS FOUND TO HAVE WHITE SPOT LIKE FUNGUS ON THE PLUNGER. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877713 ABG SYRINGE,1 ML LUER-LOK SYRINGE WITH NEEDLE. REGULAR PLUNGER STOPPER &TIP CAP. BLOOD COLLECTION SET JKA BECTON, DICKINSON AND COMPANY (BD) 5272079

    Patients

    Seq Age Sex Outcome Treatment
    1 Other