BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18784536 · Received February 26, 2024

    Report

    Report Number
    9617032-2024-00248
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 5, 2024
    Report Date
    May 9, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FPA
    UDI-DI
    50382903673440
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : MATERIAL #: 367344, LOT/BATCH #: 3173409. BD HAD NOT RECEIVED SAMPLES, BUT ONE PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR HOLDER SEPARATES DURING USE WAS OBSERVED. ADDITIONALLY, TEN RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 6 VACUTAINERS WITH WATER AND THE ISSUE OF SEPARATE DURING USE 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 OF THE HOLDER SEPARATE DURING USE. 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

    D2A. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET D2B.MEDICAL DEVICE TYPE: JKA THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. 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 WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE HOLDER SEPARATED FROM THE NEEDLE. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE HOLDER SEPARATED FROM THE NEEDLE. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120363 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON, DICKINSON AND COMPANY (BD) 3173409 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown