BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 11880944 · Received May 25, 2021

    Report

    Report Number
    1024879-2021-00328
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 22, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 5/10/2021. H.6. INVESTIGATION: BD RECEIVED 96 SAMPLES FROM LOTS: 0323060 AND 0260560 AND ONE PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, THE 30 CUSTOMER SAMPLES FROM EACH LOT WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL SLEEVE TESTING AND THE INDICATED FAILURE MODE FOR SLEEVE LEAKAGE AND DAMAGED HUB WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS FAILURE OF PRODUCT TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PLASTIC AROUND THE THREADS HAS CRACKED AND ONE LEAKED INSIDE THE HUB. ADDITIONAL INFORMATION: 5/10/2021: "THE BLOOD WAS CONTAINED TO THE HUB AND THE TUBE, WHICH WHEN REMOVED NEEDED TO BE CLEANED. THE POTENTIAL WAS PRESENT BUT WITH PROPER PPE, IT WAS ONLY ON THE GLOVES OF THE USER. "

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE POSSIBLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0323060, MEDICAL DEVICE EXPIRATION DATE: 2025-11-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0260560, MEDICAL DEVICE EXPIRATION DATE: 2025-09-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. 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 WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS FAILURE OF PRODUCT TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PLASTIC AROUND THE THREADS HAS CRACKED AND ONE LEAKED INSIDE THE HUB. ADDITIONAL INFORMATION: (B)(6) 2021: "THE BLOOD WAS CONTAINED TO THE HUB AND THE TUBE, WHICH WHEN REMOVED NEEDED TO BE CLEANED. THE POTENTIAL WAS PRESENT BUT WITH PROPER PPE, IT WAS ONLY ON THE GLOVES OF THE USER. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771122 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