BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18155122 · Received November 16, 2023

    Report

    Report Number
    9617032-2023-01651
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 9, 2023
    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
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: K220212. H.6. INVESTIGATION SUMMARY: MATERIAL #: 367338. LOT/BATCH #: 3080538. BD HAD NOT RECEIVED SAMPLES, BUT 6 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CRACKED FEMALE LUER ADAPTER WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF CRACKED FEMALE LUER ADAPTER 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 CRACKED FEMALE LUER ADAPTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    REPORT 2 OF 4. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, CRACKS WERE FOUND AT THE HUB OF THE DEVICE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPLAINT FROM (B)(6) HOSPITAL. THE CUSTOMER COMPLAINED THAT CRACKS WERE FOUND AT THE HUB OF THE BLOOD COLLECTION SETS. (DATE OF EVENT:13OCT 2023)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299202 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3080538 50382903673389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown