BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8048242 · Received November 7, 2018

    Report

    Report Number
    1024879-2018-01364
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 28, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    50382903673440
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE SAFETY LOCK ON A BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET THE BLOOD SPLATTERS ALL OVER. THERE WAS NO REPORT OF EXPOSURE TO THE MUCOSAL MEMBRANE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7230749, MEDICAL DEVICE EXPIRATION DATE: 08/31/2019, DEVICE MANUFACTURE DATE: 08/31/2017. MEDICAL DEVICE LOT #: 7257895, MEDICAL DEVICE EXPIRATION DATE: 09/30/2019, DEVICE MANUFACTURE DATE: 09/28/2017. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. ADDITIONAL COMMUNICATION WITH THE CUSTOMER INDICATES, THAT FOLLOWING COMPLETION OF BLOOD COLLECTION, THE PBBCS IV NEEDLE WAS REMOVED FROM THE PATIENT PRIOR TO ACTIVATING THE RETRACTION MECHANISM; THE USER THEN ACTIVATED THE IV NEEDLE RETRACTION MECHANISM BY PUSHING THE BUTTON. AS INDICATED IN THE PBBCS INSTRUCTIONS FOR USE, THAT FOLLOWING COMPLETION OF BLOOD COLLECTION, IT IS RECOMMENDED THAT THE USER ACTIVATE THE IV NEEDLE RETRACTION MECHANISM (BY PUSHING THE BUTTON) WHILE THE NEEDLE IS STILL WITHIN THE PATIENT. 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 WHEN USING THE SAFETY LOCK ON A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE BLOOD SPLATTERS ALL OVER. THERE WAS NO REPORT OF EXPOSURE TO THE MUCOSAL MEMBRANE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888397 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10. 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    0 Other