BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8453960 · Received March 26, 2019

    Report

    Report Number
    1024879-2019-00646
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    December 13, 2018
    Report Date
    May 7, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673655
    PMA / PMN Number
    K153309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: 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 THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED BLOOD SPATTER/LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: DURING THE BLOOD COLLECTION THE BLOOD LEAKED FROM THE CANULLA UNDERNEATH THE GREEN WINGS THE CUSTOMER REPORTED THAT BLOOD WAS LEAKING FROM THE DEVICE FROM BELOW THE WINGS OF THE WINGSET. THE CUSTOMER DID NOT SPECIFY WHERE EXACTLY THE LEAKAGE WAS LOCATED (CANNULA OR TUBING OR ELSE).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: JKA; FPA. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET (B)(6). 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 THAT THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED BLOOD SPATTER/LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: DURING THE BLOOD COLLECTION THE BLOOD LEAKED FROM THE CANULLA UNDERNEATH THE GREEN WINGS. THE CUSTOMER REPORTED THAT BLOOD WAS LEAKING FROM THE DEVICE FROM BELOW THE WINGS OF THE WINGSET. THE CUSTOMER DID NOT SPECIFY WHERE EXACTLY THE LEAKAGE WAS LOCATED (CANNULA OR TUBING OR ELSE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246965 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 8127566 50382903673655

    Patients

    Seq Age Sex Outcome Treatment
    1 Other