BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER

    MDR report key: 10708759 · Received October 20, 2020

    Report

    Report Number
    2243072-2020-01684
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    July 22, 2020
    Report Date
    December 1, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D10: RETURNED TO MANUFACTURER ON: (B)(6)2020. H6: INVESTIGATION SUMMARY BD RECEIVED 21 SAMPLES FOR INVESTIGATION. 10 SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. ADDITIONALLY 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY LEAK TEST AND NO ISSUES WERE OBSERVED RELATION TO LEAKAGE 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. BD WAS NOT ABLE TO IDENTIFIY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE FEMALE LUER ADAPTER THE DEVICE TUBE WAS UNABLE TO FILL COMPLETELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "BLOOD WAS COLLECTED USING BD SYRINGE 300296 ( 20 ML), AND THEN TRANSFERRED TO EDTA 2ML 368841 TUBE VIA BTD LOT 9113601 AT INTENSIVE CARE. IT WAS SEEN THAT TUBE WAS NOT FILLED PROPERLY."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT, AND WITHOUT THIS INFORMATION, WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED, AND (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE FEMALE LUER ADAPTER THE DEVICE TUBE WAS UNABLE TO FILL COMPLETELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED, "BLOOD WAS COLLECTED USING BD SYRINGE 300296 ( 20 ML), AND THEN TRANSFERRED TO EDTA 2ML 368841 TUBE VIA BTD LOT 9113601 AT INTENSIVE CARE. IT WAS SEEN THAT TUBE WAS NOT FILLED PROPERLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173826 BD VACUTAINER BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 9113601

    Patients

    Seq Age Sex Outcome Treatment
    1