BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN.

    MDR report key: 9188167 · Received October 14, 2019

    Report

    Report Number
    9610847-2019-00621
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 17, 2019
    Report Date
    November 4, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833123
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8212735. OUR RECORDS SHOW THAT THIS IS THE SECOND 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE. UNFORTUNATELY 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN. HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT FOREIGN MATTER IS ON THE NEEDLE TIP AFTER UNWRAPPED THE PACKAGE/DURING PRIMING. ON (B)(6) 2019, WHEN THE NURSE PERFORMED A PRE-USE EXAMINATION FOR THE PATIENT'S RETENTION NEEDLE PUNCTURE, IT WAS FOUND THAT THERE WAS A FOREIGN OBJECT ON THE TIP OF THE NEEDLE AND REPLACED IT IMMEDIATELY. NOT APPLIED TO PATIENTS, NO IMPACT ON PATIENTS.

    Additional Manufacturer Narrative · 1

    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 24 G X 0.75 IN. HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT FOREIGN MATTER IS ON THE NEEDLE TIP AFTER UNWRAPPED THE PACKAGE/DURING PRIMING ON (B)(6) 2019, WHEN THE NURSE PERFORMED A PRE-USE EXAMINATION FOR THE PATIENT'S RETENTION NEEDLE PUNCTURE, IT WAS FOUND THAT THERE WAS A FOREIGN OBJECT ON THE TIP OF THE NEEDLE AND REPLACED IT IMMEDIATELY. NOT APPLIED TO PATIENTS, NO IMPACT ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983507 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN. INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8212735 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other