BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WINGSET PBBCS 21 X .75 12 PREATTACHED

    MDR report key: 6999550 · Received November 3, 2017

    Report

    Report Number
    1024879-2017-00231
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    May 16, 2016
    Report Date
    October 26, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673520
    PMA / PMN Number
    K011984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BATCH 6021896 FOUR CUSTOMER SAMPLES WERE RECEIVED WITH SEVERED TUBING. BATCH 5343757 ONE CUSTOMER SAMPLE WAS RECEIVED WITH SEVERED TUBING. AS THIS IS A CONFIRMED COMPLAINT A DHR REVIEW IS NOT REQUIRED REFER TO CAPA 50210 FOR INVESTIGATION SUMMARY. CONCLUSION: CAPA (B)(4) HAS BEEN INITIATED FOR DOCUMENTATION RELATED TO THIS ISSUE OF SEVERED TUBING TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS AND REMEDIATION PLAN TO INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS. ROOT CAUSE: JUST BEFORE THE SEALING PROCESS IF THE TUBING IS HANGING OUTSIDE OF THE BOTTOM BLISTER CAVITY, THE TUBING CAN BE SEVERED. REMEDIAL ACTION REQUIRED: CAPA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE 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 BEFORE USING THE WINGSET PBBCS 21 X .75 12 PREATTACHED THE USER NOTED THAT THE TUBING WAS PINCHED AND SOMETIMES COMPLETELY SEVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779959 WINGSET PBBCS 21 X .75 12 PREATTACHED BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6021896 00382903673520

    Patients

    Seq Age Sex Outcome Treatment
    1 Other