BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 7067198 · Received November 29, 2017

    Report

    Report Number
    1024879-2017-00391
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    April 13, 2016
    Report Date
    October 30, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903686520
    PMA / PMN Number
    K980414
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: A PHOTO WAS RECEIVED SHOWING THE DEFECT. A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5033565. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CAPA 35136 HAS BEEN INITIATED TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS AND REMEDIATION PLAN TO INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, 21G 7IN TUBING HAD NO NEEDLE COVER. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848912 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD COLLECTION NEEDLE JKA BECTON, DICKINSON & CO., (BD) 5033565 00382903686520

    Patients

    Seq Age Sex Outcome Treatment
    1 Other