BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 18866722 · Received March 8, 2024

    Report

    Report Number
    1024879-2024-00205
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 13, 2024
    Report Date
    April 4, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    30382903686095
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. INITIAL REPORTER EMAIL: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES D.9:DEVICE EVAL BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 2024-MARCH- 26TH H.6 INVESTIGATION SUMMARY MATERIAL #: 368609 LOT/BATCH #: 3163529. BD RECEIVED 4 SHELF CARTONS OF SAMPLES FOR INVESTIGATION. TWENTY (20) OF THE SAMPLES WERE CHOSEN AT RANDOM AND EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR HUB-COLLAR SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO HUB-COLLAR SEPARATION AS ALL SAMPLES MET SPECIFICATIONS. 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE HUB-COLLAR SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE HOLDER DETACHES FROM THE NEEDLE WHILE CHANGING BOTTLES DURING VENIPUNCTURE. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE HOLDER DETACHES FROM THE NEEDLE WHILE CHANGING BOTTLES DURING VENIPUNCTURE. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163076 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 3163529 30382903686095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown