BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 19037286 · Received April 3, 2024

    Report

    Report Number
    9617032-2024-00489
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 4, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FPA
    UDI-DI
    00382903673384
    PMA / PMN Number
    K220212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY MATERIAL #: 367338; LOT/BATCH #: 3187575. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING SHELF PACK LABEL WAS OBSERVED. ADDITIONALLY, 2 RETENTION SHELF PACKS FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF MISSING SHELF PACK LABEL 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 MISSING SHELF PACK LABEL. 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.

    Additional Manufacturer Narrative · 0

    D2A: COMMON DEVICE NAME; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET. D.2B: MEDICAL DEVICE TYPECHECK SPELLING: FPA, JKA. G.5 PMA / 510(K)#: K220212, K030573. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE SHELF PACKAGING BOX WAS MISSING ITS LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE SHELF PACKAGING BOX WAS MISSING ITS LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447439 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON, DICKINSON AND COMPANY (BD) 3187575 00382903673384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown