BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® WINGED SAFETY PBBCS WITH TUBING

    MDR report key: 7152733 · Received December 28, 2017

    Report

    Report Number
    1710034-2017-00488
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 6, 2017
    Report Date
    January 16, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT # PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW OF POTENTIAL LOT NUMBERS WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION:  FOUR POTENTIAL LOT NUMBERS WERE PROVIDED FOR THE PREVIOUSLY REPORTED INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7030628, MEDICAL DEVICE EXPIRATION DATE: 2/28/2019, DEVICE MANUFACTURE DATE: 1/30/2017. MEDICAL DEVICE LOT #: 7030619, MEDICAL DEVICE EXPIRATION DATE: 2/28/2019, DEVICE MANUFACTURE DATE: 1/30/2017. MEDICAL DEVICE LOT #: 7030592, MEDICAL DEVICE EXPIRATION DATE: 2/28/2019, DEVICE MANUFACTURE DATE: 1/30/2017.  MEDICAL DEVICE LOT #: 7013816, MEDICAL DEVICE EXPIRATION DATE: 1/31/2019, DEVICE MANUFACTURE DATE: 1/13/2017. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, THE LOT NUMBER INVOLVED IN THIS INCIDENT COULD NOT BE CONFIRMED BY THE CUSTOMER; THEREFORE, ALL POTENTIAL LOT NUMBERS INDICATED BY THE CUSTOMER WERE INVESTIGATED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR EACH POTENTIAL LOT NUMBER 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. 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 A BD VACUTAINER® WINGED SAFETY PBBCS WITH TUBING THE BARREL SEPARATED AND BLOOD LEAKED ONTO THE HEALTHCARE WORKERS PPE AND THE PATIENT¿S SKIN AND BED. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930151 BD VACUTAINER® WINGED SAFETY PBBCS WITH TUBING BLOOD COLLECTION SET JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other