BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 10574905 · Received September 23, 2020

    Report

    Report Number
    1024879-2020-00656
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 13, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED 1 SAMPLES AND 1 PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR HUB/COLLAR SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR HUB/COLLAR SEPARATION WITH THE INCIDENT LOT WAS 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF HUB/COLLAR SEPARATION THROUGH A CORRECTIVE AND PREVENTIVE ACTION (CAPA#1277214).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE PROTECTIVE CAP CAME OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 3 COMPLAINTS). IT WAS REPORTED THAT THE SAFETY CAP IS COMING OFF WITH THE SEALED CAP.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE ACTUAL LOT# IS UNKNOWN, HOWEVER, THERE WERE MULTIPLE LOT NUMBERS REPORTED TO POSSIBLY BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0120400, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-29, MEDICAL DEVICE LOT #: 0120391, HOWEVER THIS IS NOT A LOT# FOR THIS PRODUCT. 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 PRIOR TO USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE PROTECTIVE CAP CAME OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 3 COMPLAINTS). IT WAS REPORTED THAT THE SAFETY CAP IS COMING OFF WITH THE SEALED CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041644 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 SEE H.10 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other