BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 7148821 · Received December 27, 2017

    Report

    Report Number
    1024879-2017-01317
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    December 8, 2017
    Report Date
    January 31, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    00382903686513
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7200785. MEDICAL DEVICE EXPIRATION DATE: 07/31/2020. DEVICE MANUFACTURE DATE: 07/19/2017. MEDICAL DEVICE LOT #: 7265915. MEDICAL DEVICE EXPIRATION DATE: 09/30/2020. DEVICE MANUFACTURE DATE: 09/22/2017. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: BD RECEIVED SAMPLES FROM LOT 7200785 FROM THE CUSTOMER FACILITY FOR INVESTIGATION; NO SAMPLES WERE RECEIVED FROM LOT 7265915. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR SAFETY SHIELD SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. EACH SAMPLE WAS HAND ACTIVATED TO EVALUATE THE FUNCTION OF THE SAFETY SHIELD. THE SAFETY SHIELD WAS ROTATED BACKWARDS WITH EASE WITH NO IV SHIELD LIFT IDENTIFIED. THE SAFETY SHIELD WAS THEN ENGAGED OVER THE IV NEEDLE. THE LOCK-OUT FEATURES ENGAGED APPROPRIATELY AND NO BREAKAGE, FULL OR PARTIAL DISENGAGEMENT OF THE SAFETY SHIELD FROM THE BODY OF THE UNIT WAS IDENTIFIED. 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 (B)(4) 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. BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR SAFETY SHIELD SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. HOWEVER, 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. BD HAS INITIATED FURTHER INVESTIGATION THROUGH CAPA (B)(4). 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 PINK SAFETY LID TO THE BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER IS MISALIGNED AND WHEN THE PHLEBOTOMIST GOES TO PUSH IT UP WITH THEIR THUMB, THE DEVICE WILL NOT GO OVER THE NEEDLE AND, IN SOME CASES, FALLS OFF. FOUND DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928761 BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10. 00382903686513

    Patients

    Seq Age Sex Outcome Treatment
    1 Other