BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    MDR report key: 19208060 · Received April 29, 2024

    Report

    Report Number
    9617032-2024-00658
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 4, 2024
    Report Date
    April 30, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903602101
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H.6 INVESTIGATION SUMMARY: MATERIAL #: 360210. LOT/BATCH #: 4003277. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND NO ISSUES WERE OBSERVED RELATING TO INSUFFICIENT BLOOD FLOW 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 INSUFFICIENT BLOOD FLOW. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE THAT THERE WAS AN ISSUE WITH INSUFFICIENT BLOOD FLOW DURING COLLECTION REQUIRING THE SAMPLE TO BE RECOLLECTED. NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE THAT THERE WAS AN ISSUE WITH INSUFFICIENT BLOOD FLOW DURING COLLECTION REQUIRING THE SAMPLE TO BE RECOLLECTED. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419862 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE JKA BECTON, DICKINSON AND COMPANY (BD) 4003277 30382903602101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown