BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8716328 · Received June 20, 2019

    Report

    Report Number
    1710034-2019-00645
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    June 3, 2019
    Report Date
    August 7, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    50382903673242
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR SEPARATION OF THE FRONT (WING) AND REAR BARREL COMPONENTS WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND DAMAGE TO THE REAR BARREL WAS OBSERVED. 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 SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR FRONT/REAR BARREL SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, 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 WINGS BROKE OFF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED THAT THE WINGS BROKE OFF ITEM 367324, LOT 9031968 DURING USE."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. MEDICAL DEVICE TYPE: FPA. 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 WINGS BROKE OFF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED THAT THE WINGS BROKE OFF ITEM 367324, LOT 9031968 DURING USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508553 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9031968 50382903673242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other