BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9083594 · Received September 18, 2019

    Report

    Report Number
    1024879-2019-01667
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 29, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686563
    PMA / PMN Number
    K011984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. AS OF AUGUST 2, 2019 THIS LOT NUMBER IS UNDER THE SCOPE OF FIELD ACTION # PAS-19-1567. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THIS BATCH. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THIS BATCH. PRODUCT WAS MANUFACTURED AT THE BD (B)(4) SITE MARCH 30, 2019 THRU APRIL 01, 2019. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RETRACTION ISSUE OCCURRED DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CUSTOMER STATED THAT SHE HAD TO REALLY PUSH DOWN IN ORDER FOR THE NEEDLE TO RETRACT AND IT RETRACTED VERY SLOWLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879074 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE FMI BECTON, DICKINSON & CO., (BD) 9086811 50382903686563

    Patients

    Seq Age Sex Outcome Treatment
    1 Other