BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA 1.00IN (0.9 X 25 MM)

    MDR report key: 9873748 · Received March 24, 2020

    Report

    Report Number
    1710034-2020-00206
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    February 6, 2020
    Report Date
    May 5, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE FOLLOWING INFORMATION HAS BEEN UPDATED: THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9270764. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. H.4. DEVICE MANUFACTURE DATE: 2019-09-27. D.4. MEDICAL DEVICE LOT #: 9212069. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. H.4. DEVICE MANUFACTURE DATE: 2019-07-31.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE PICTURES SUBMITTED FOR EVALUATION. BD RECEIVED THREE PHOTOGRAPHS WHICH DISPLAYED A 22GA INSYTE IV CATHETER UNIT WITH BLACK SPECKS OBSERVED NEAR THE GRIP, NEEDLE COVER AND BARREL. THE PACKAGING APPEARS TO BE SEALED. THE REPORTED ISSUE WAS CONFIRMED AS FOREIGN MATTER WAS OBSERVED. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, WE WERE UNABLE TO DETERMINE A ROOT CAUSE WITHOUT PERFORMING TESTING ON THE ACTUAL UNIT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 32 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS 22GA 1.00IN (0.9 X 25 MM) EXPERIENCED FOREIGN MATTER IN OR ON THE DEVICE CANNULA/NEEDLE/CATHETER. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCTS WITH FOREIGN PARTICLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 32 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS 22GA 1.00IN (0.9 X 25 MM) EXPERIENCED FOREIGN MATTER IN OR ON THE DEVICE CANNULA/NEEDLE/CATHETER. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCTS WITH FOREIGN PARTICLES.

    Additional Manufacturer Narrative · 1

    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 32 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS 22GA 1.00IN (0.9 X 25 MM) EXPERIENCED FOREIGN MATTER IN OR ON THE DEVICE CANNULA/NEEDLE/CATHETER. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCTS WITH FOREIGN PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339677 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA 1.00IN (0.9 X 25 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381823 SEE H.10 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other