BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8848346 · Received July 31, 2019

    Report

    Report Number
    9610048-2019-00246
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 4, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WERE NO SAMPLES OR PHOTOS AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WOULD FOLD EASILY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT DOES NOT PRESENT INFORMATION ON THE PACKAGING OF THE MATERIAL USED IN THE MANUFACTURING (SUSPECTED TO BE SILICONE), THE PRODUCT (CATHETER) FOLDS EASILY (VERY FLEXIBLE) WHICH HINDERS THE VENOUS ACCESS OR IT BENDS AND DOES NOT PROGRESS IN THE VESSEL.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6362782, MEDICAL DEVICE EXPIRATION DATE: 2019-07-31, DEVICE MANUFACTURE DATE: 2017-01-18. MEDICAL DEVICE LOT #: 8040632, MEDICAL DEVICE EXPIRATION DATE: 2020-09-30, DEVICE MANUFACTURE DATE: 2018-02-27. 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 WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WOULD FOLD EASILY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT DOES NOT PRESENT INFORMATION ON THE PACKAGING OF THE MATERIAL USED IN THE MANUFACTURING (SUSPECTED TO BE SILICONE), THE PRODUCT (CATHETER) FOLDS EASILY (VERY FLEXIBLE) WHICH HINDERS THE VENOUS ACCESS OR IT BENDS AND DOES NOT PROGRESS IN THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638657 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER N/A FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SEE H.10 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other