BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 7081147 · Received December 4, 2017

    Report

    Report Number
    1024879-2017-00903
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    September 27, 2016
    Report Date
    November 2, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903686568
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: TWO SAMPLES WERE RETURNED FOR EVALUATION. THE PHOTO AND THE SAMPLES CONFIRMED THE OPEN PACKAGES WITH RED TAPE THROUGH VISUAL INSPECTIONS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #6200697. CONCLUSION: THE MOST LIKELY CAUSE IS ROLL SPLICING DURING A TOP WEB ROLL CHANGE. THE TWO PACKAGES WERE NOT DETECTED AND INADVERTENTLY PACKED OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAD 2 OF THE 20 PACKAGES IN THE BOX OPEN AND MARKED WITH RED TAPE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857709 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6200697 00382903686568

    Patients

    Seq Age Sex Outcome Treatment
    1 Other