BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

    MDR report key: 8660400 · Received May 31, 2019

    Report

    Report Number
    9617032-2019-00639
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 3, 2019
    Report Date
    June 14, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS AND SAMPLES WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR EXCESS BLOOD IN THE FLASH CHAMBER WAS OBSERVED. LEAKAGE WAS NOT IDENTIFIED BY THE PHOTOS OR SAMPLES. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS AND SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR EXCESS BLOOD IN THE FLASH CHAMBER WITH THE INCIDENT LOT WAS OBSERVED; HOWEVER, NO EXTERNAL LEAKAGE WAS IDENTIFIED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE OF EXCESS BUILD-UP OF BLOOD WITHIN THE FLASH CHAMBER WAS DETERMINED TO BE RELATED TO A USER-RELATED ISSUE. A ROOT CAUSE OF THE LEAKAGE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EIGHTEEN BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLES WITH INTEGRATED HOLDERS EXPERIENCED INSUFFICIENT BLOOD FLOW, AND BLOOD SPATTER/LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING BLOOD COLLECTION, AFTER VISUALIZING THE PRESENCE IN THE VEIN IN THE FLASH, THE TUBE IS CONNECTED AND THE FILTER CHAMBER IS FLOODED WITH BLOOD UNTIL THE BLOOD FLOW TO THE TUBE IS BLOCKED, AND THE BLOOD FLOWS OUT OF THE DEVICE. THEY USED TUBES BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8075971. MEDICAL DEVICE EXPIRATION DATE: 2021-03-31. DEVICE MANUFACTURE DATE: 2018-03-16. MEDICAL DEVICE LOT #: 8110883. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2018-04-20. MEDICAL DEVICE LOT #: 8264841. MEDICAL DEVICE EXPIRATION DATE: 2021-09-30. DEVICE MANUFACTURE DATE: 2018-09-21.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EIGHTEEN BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLES WITH INTEGRATED HOLDERS EXPERIENCED INSUFFICIENT BLOOD FLOW, AND BLOOD SPATTER/LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING BLOOD COLLECTION, AFTER VISUALIZING THE PRESENCE IN THE VEIN IN THE FLASH, THE TUBE IS CONNECTED AND THE FILTER CHAMBER IS FLOODED WITH BLOOD UNTIL THE BLOOD FLOW TO THE TUBE IS BLOCKED, AND THE BLOOD FLOWS OUT OF THE DEVICE. THEY USED TUBES BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452109 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other