BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    MDR report key: 20418109 · Received October 10, 2024

    Report

    Report Number
    9617032-2024-01637
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 13, 2024
    Report Date
    September 23, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    UDI-DI
    30382903602118
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL LOT NUMBER REPORTED: D4. MEDICAL DEVICE LOT#: 2011536; D4. MEDICAL DEVICE EXPIRATION DATE: 01/31/2027; D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 01/11/2022. E1. INITIAL REPORTER PHONE AND FACILITY NAME: (B)(6). INVESTIGATION SUMMARY: "MATERIAL #: 360211 LOT/BATCH #: 1355174 AND 2011536. BD RECEIVED 10 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR LABEL LIFT WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES OF EACH REPORTED LOT NUMBER FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF LABEL LIFT 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 LABEL LIFT. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLES, AN UNSPECIFIED NUMBER OF DEVICES HAD UNIT SEAL LABELS THAT WERE LIFTING OR MISSING. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934220 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 1355174 30382903602118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown