BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 19088141 · Received April 11, 2024

    Report

    Report Number
    9617032-2024-00558
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 12, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FPA
    UDI-DI
    00382903673445
    PMA / PMN Number
    K220212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A. :COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET D2B. MEDICAL DEVICE TYOE: FPA, JKA. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: E.1: INITIAL REPORTER ADDR 1: (B)(6) E.1: INITIAL REPORTER ZIP: (B)(6) H.6 INVESTIGATION SUMMARY MATERIAL #: 367344 LOT/BATCH #: 3173409 BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, TEN (10) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO CRACKED COMPONENT AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF CRACKED COMPONENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THERE WAS LEAKING DUE TO A MINUTE CRACK IN THE HUB. NO EXPOSURE TO BLOOD BUT 5 OR 6 PATIENTS NEEDED TO BE STUCK TWICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THERE WAS LEAKING DUE TO A MINUTE CRACK IN THE HUB. NO EXPOSURE TO BLOOD BUT 5 OR 6 PATIENTS NEEDED TO BE STUCK TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446162 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON, DICKINSON AND COMPANY (BD) 3173409 00382903673445

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown