BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18446574 · Received January 4, 2024

    Report

    Report Number
    9617032-2023-01887
    Event Type
    Malfunction
    Date Received
    January 4, 2024
    Date of Event
    December 17, 2023
    Report Date
    February 20, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903673389
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY MATERIAL #: (B)(4) LOT/BATCH #: (B)(4) BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR LEAKAGE WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE ISSUE OF LEAKAGE WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDR 1: (B)(6). G5: PMA/510(K)#: K220212. H.3. 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 · 0

    IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE WINGSET LEAKED BLOOD FROM THE BARREL WHEN THE SAFETY FEATURE WAS TRIGGERED. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE WINGSET LEAKED BLOOD FROM THE BARREL WHEN THE SAFETY FEATURE WAS TRIGGERED. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575108 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BECTON, DICKINSON AND COMPANY (BD) 3069588 50382903673389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown