BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 G X 1.25 IN. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 6315925 · Received February 9, 2017

    Report

    Report Number
    1024879-2017-00016
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Date of Event
    January 24, 2017
    Report Date
    April 10, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    77523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO LOT NUMBERS WERE REPORTED FOR THIS INCIDENT. THE FOLLOWING INFORMATION IS FOR EACH LOT #: MEDICAL DEVICE LOT #: 6231990, MEDICAL DEVICE EXPIRATION DATE: 8/31/2021, DEVICE MANUFACTURE DATE: 8/16/2016. MEDICAL DEVICE LOT #: 6252540, MEDICAL DEVICE EXPIRATION DATE: 8/31/2021, DEVICE MANUFACTURE DATE: 9/8/2016. (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS NOT MARKETED IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE FROM LOT # 6231990 AND TWO USED SAMPLES FROM LOT # 6252540 WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION OF ALL THREE SAMPLES EXHIBITED HUB COLLAR SEPARATION. AS THIS IS A CONFIRMED COMPLAINT, A DHR REVIEW IS NOT REQUIRED. REFER TO CAPA (B)(4) FOR COMPLETE DOCUMENTATION AND ACTION PLANS. CONCLUSION: ALTHOUGH THE CUSTOMER'S INDICATED FAILURE MODE WAS CONFIRMED, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT HAS NOT BEEN DETERMINED. REMEDIAL ACTION REQUIRED: CAPA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS, AND REMEDIATION PLAN TO INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GREEN SAFETY SHIELD CAME OFF OF A 21 G X 1.25 IN. BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE DURING USE, LEAVING AN EXPOSED NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97069 21 G X 1.25 IN. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other