BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 22 G X 0.75 IN.

    MDR report key: 9318650 · Received November 13, 2019

    Report

    Report Number
    9610847-2019-00682
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 9, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833222
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9143633. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. BASED ON PHOTO EVALUATION, EXPOSED NEEDLE WAS OBSERVED IN THE SAFETY DEVICE. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE. A PHYSICAL SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. THE ENGINEERING TEAM COULD REPRODUCE THE DEFECT BY APPLYING TOO MUCH FORCE DURING THE ACTIVATION. THIS EXCESSIVE FORCE CAUSED DAMAGE IN THE INTERNAL DIAMETER OF THE INNER/OUTER ASSEMBLY, LEAVING THE EXPOSED NEEDLE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 22 G X 0.75 IN. HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SAFETY DID NOT ENGAGE. WE HAD A DEFECT IN ONE OF OUR INTIMA CATHETERS TODAY IN CHEMO. THE SAFETY DID NOT ENGAGE AND WE WERE ABLE TO TAKE A PICTURE. WE DID NOT SAVE THE NEEDLE SINCE IT WAS A SHARP. I ALSO SAVED THE LOT NUMBER IF YOU NEEDED IT (9143633).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 22 G X 0.75 IN. HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SAFETY DID NOT ENGAGE. WE HAD A DEFECT IN ONE OF OUR INTIMA CATHETERS TODAY IN CHEMO. THE SAFETY DID NOT ENGAGE AND WE WERE ABLE TO TAKE A PICTURE. WE DID NOT SAVE THE NEEDLE SINCE IT WAS A SHARP. I ALSO SAVED THE LOT NUMBER IF YOU NEEDED IT (9143633).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108353 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 22 G X 0.75 IN. INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9143633 30382903833222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other