BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 9361635 · Received November 22, 2019

    Report

    Report Number
    1024879-2019-02021
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 12, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673419
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET NEEDLE DID NOT RETRACT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367341, BATCH NO. 9091633. IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. AFTER BLOOD DRAW, PHLEBOTOMIST PRESSED BUTTON TO RETRACT NEEDLE (SAFETY FEATURE) AND THE NEEDLE DID NOT RETRACT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. ADDITIONAL MEDICAL DEVICE TYPE: FPA. ADDITIONAL COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET NEEDLE DID NOT RETRACT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367341, BATCH NO. 9091633. IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. AFTER BLOOD DRAW, PHLEBOTOMIST PRESSED BUTTON TO RETRACT NEEDLE (SAFETY FEATURE) AND THE NEEDLE DID NOT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161001 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9091633 50382903673419

    Patients

    Seq Age Sex Outcome Treatment
    1 Other