BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 9819192 · Received March 11, 2020

    Report

    Report Number
    1024879-2020-00193
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 20, 2020
    Report Date
    April 10, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, 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 INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA 1465371. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE THE SAFETY SHIELD DETACHED WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY SHIELD DETACHED FROM NEEDLE- POSSIBLY PROBLEM WITH GLUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9136978. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-05-29. MEDICAL DEVICE LOT #: 9241835. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-11-07. MEDICAL DEVICE LOT #: 9249101. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-09-16. " A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THE SAFETY SHIELD DETACHED WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY SHIELD DETACHED FROM NEEDLE- POSSIBLY PROBLEM WITH GLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285286 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other