BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER

    MDR report key: 12255005 · Received July 30, 2021

    Report

    Report Number
    1710034-2021-00646
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 1, 2021
    Report Date
    September 13, 2021
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0171699. D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2023. H.4. DEVICE MANUFACTURE DATE: 6/19/2020. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED THREE PHOTOS. A SAMPLE WAS ALSO PROVIDED BUT UNFORTUNATELY THE SAMPLE APPEARS TO HAVE BEEN LOST IN TRANSIT. UPON INSPECTION OF THE PHOTOS, IT WAS FOUND THAT A V SHAPE CUT WAS PRESENT INSIDE OF THE CATHETER TUBING WHICH IS INDICATIVE OF THE NEEDLE PIERCING THROUGH THE CATHETER WALL. YOUR REPORTED DEFECT WAS CONFIRMED. THIS TYPE OF DEFECT CAN OCCUR DURING THE MANUFACTURING PROCESS OR IN THE CLINICAL SETTING. IF THE DEFECT OCCURRED DURING THE MANUFACTURING PROCESS, THE UNIT WOULD HAVE LIKELY ARRIVED WITH THE NEEDLE STILL THROUGH THE CATHETER. SINCE THE PACKAGE HAD BEEN OPENED IT IS ALSO POSSIBLE THE DEFECT OCCURRED DURING TIP ADHESION BREAK OR THE VENIPUNCTURE ATTEMPT. IT WAS ALSO NOTED IN THE PHOTOS THAT THE CATHETER TUBING WAS SITTING HIGH ON THE NEEDLE BEVEL WHICH INDICATIVE OF THE TIP ADHESION BEING BROKEN; THEREFORE, THE DEFECT OCCURRING DURING USE COULD NOT BE RULED OUT. BASED ON THE INFORMATION AVAILABLE, BD COULD NOT DETERMINE WITH CERTAINTY IF THE DEFECT OCCURRED DURING MANUFACTURING OR IN THE USER ENVIRONMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER TIP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THE CUSTOMER REPORTED THAT THE CATHETER TIP WAS DAMAGED."

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # 0171699 WAS NOT FOUND FOR THE REPORTED CATALOG # 381912. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER TIP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CUSTOMER REPORTED THAT THE CATHETER TIP WAS DAMAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148097 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ 0171699

    Patients

    Seq Age Sex Outcome Treatment
    1