BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 10830439 · Received November 12, 2020

    Report

    Report Number
    1024879-2020-00833
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 22, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED 1 SAMPLES AND 1 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS OBSERVED AS NOT ALL PRODUCT SPECIFICATIONS WERE MET. 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. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF DEFECTIVE LOCKING MECHANISM THROUGH CAPA#1465371.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON OCTOBER 22, 2020, WHEN THE BLOOD COLLECTOR PRESSED THE SAFETY LOCK WHEN THE BLOOD COLLECTION WAS COMPLETED, THE LOCK WAS FOUND TO FALL OFF. USE PRODUCT NUMBER 368607, BATCH NUMBER 0171601.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ON (B)(6) 2020, WHEN THE BLOOD COLLECTOR PRESSED THE SAFETY LOCK WHEN THE BLOOD COLLECTION WAS COMPLETED, THE LOCK WAS FOUND TO FALL OFF. USE PRODUCT NUMBER 368607, BATCH NUMBER 0171601.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298311 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 0171601 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1