BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER BLOOD TRANSFER DEVICE WITH LUER ADAPTER

    MDR report key: 6859048 · Received September 12, 2017

    Report

    Report Number
    2618282-2017-00017
    Event Type
    Injury
    Date Received
    September 12, 2017
    Date of Event
    August 18, 2017
    Report Date
    November 3, 2017
    Manufacturer
    BD CARIBE LTD.
    Product Code
    FMI
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A DEVICE HISTORY REVIEW WAS NOT CONDUDCTED BECAUSE A LOT NUMBER COULD NOT BE DETERMINED. CONCLUSION: BD WAS UNABLE TO CONFIRM THE CUSTOMERS INDICATED FAILURE MODE BECAUSE NO SAMPLES OR PHOTOS WERE RECEIVED TO CONFIRM THE STATED DEFECT. (B)(4).

    Additional Manufacturer Narrative · 1

    BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES OF THE POTENTIAL LOT NUMBERS LISTED IN THE COMPLAINT DESCRIPTION (MATERIAL NUMBER: 364880, LOT NUMBERS: 7108641, 7059515, 7062578, 7143969) WERE SELECTED FROM BD INVENTORY FOR EVALUATION & TESTING AND UPON COMPLETION, NO ISSUES OR DEFECTS WAS OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS ALSO COMPLETED FOR EACH OF THE POTENTIAL INCIDENT LOTS 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. CONCLUSION: BASED ON EVALUATION OF THE RETAIN SAMPLES OF THE POTENTIAL INCIDENT LOT NUMBERS, NO ISSUES OR DEFECTS WAS OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE RETAIN PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. 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 · 1

    IT WAS REPORTED THAT WHILE COLLECTING BLOOD WITH A BD VACUTAINER¿ BLOOD TRANSFER DEVICE WITH LUER ADAPTER, NURSE WAS EXPOSED TO PATIENTS BLOOD POTENTIALLY INTO HER EYES. NURSE RECEIVED POST EXPOSURE LAB WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639661 BD VACUTAINER BLOOD TRANSFER DEVICE WITH LUER ADAPTER BLOOD COLLECTION SET FMI BD CARIBE LTD. UNKNOWN
    639662 BD VACUTAINER BLOOD TRANSFER DEVICE WITH LUER ADAPTER BLOOD COLLECTION SET JKA BD CARIBE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention