BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 7248594 · Received February 7, 2018

    Report

    Report Number
    1024879-2018-00029
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    December 26, 2017
    Report Date
    January 22, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686501
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7200781; MEDICAL DEVICE EXPIRATION DATE: 2020-07-31; DEVICE MANUFACTURE DATE: 2017-07-19. MEDICAL DEVICE LOT #: 7221921; MEDICAL DEVICE EXPIRATION DATE: 2020-07-31; DEVICE MANUFACTURE DATE: 2017-08-09. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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 A CAPA AND POTENTIAL CAUSES FROM THE MANUFACTURING PROCESS HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED RELATING TO THIS PRODUCT ISSUE AND POSSIBLE ROOT CAUSES FROM THE MANUFACTURING PROCESS HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH A CAPA. THE INVESTIGATION HAS IDENTIFIED POSSIBLE ROOT CAUSES FROM THE MANUFACTURING PROCESS AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS PRODUCT ISSUE. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FROM THE MANUFACTURING PROCESS FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE SAFETY CLIP OF A BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER, FELL OFF DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90440 BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other