BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 18959275 · Received March 22, 2024

    Report

    Report Number
    1024879-2024-00257
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 11, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903686532
    PMA / PMN Number
    K980414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. E1. INITIAL REPORTER FACILITY NAME: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: K991088. H4. DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION SUMMARY: MATERIAL #: 368653. LOT/BATCH #: UNKNOWN. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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 SEPARATES PRIOR TO USE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE ADAPTER WAS DETACHED FROM THE HOLDER OF ONE (1) DEVICE. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554169 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) UNKNOWN 50382903686532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown