BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 12125429 · Received July 6, 2021

    Report

    Report Number
    1710034-2021-00547
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 7, 2021
    Report Date
    August 4, 2021
    Product Code
    FOZ
    UDI-DI
    30382903814238
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-06-21. H6: INVESTIGATION SUMMARY ONE USED 22GA BD INSYTE AUTOGUARD IV CATHETER DEVICES WITHIN AN UNDAMAGED OPENED PACKAGE FROM PRODUCT REF. #381423, LOT #1032453 WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE UNIT IS WITH ALL COMPONENTS PRESENT SANS THE CATHETER ADAPTER ASSEMBLY. THERE ARE TRACES OF MEDIA PRESENT IN THE FLASHBACK CHAMBER. VISUAL OBSERVATION REVEALS THAT THE ACTIVATION BUTTON IS DEPRESSED AND THE NEEDLE IS IN THE FULLY OUT POSITION AND SLIGHTLY BENT AT THE HUB. VISUAL OBSERVATION REVEALS TRACES OF CURED ADHESIVE BETWEEN THE HUB AND THE GRIP THAT HINDERED A FULL RETRACTION OF THE NEEDLE. FUNCTIONAL TESTING FOR NEEDLE RETRACTION WAS CONDUCTED AT WHICH POINT THE BUTTON COMPLETELY DEPRESSED AND THE NEEDLE DID NOT RETRACT, THEREFORE VERIFYING THE REPORTED DEFECT. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. DURING MANUFACTURING AT THE ADHESIVE DISPENSE PROCESS, ADHESIVE ON THE OUTSIDE OF THE HUB, IN THE GRIP AND / OR THE BUTTON CAN OCCUR DUE TO STATION MISALIGNMENT AND RESULT IN THE FAILURE OF NEEDLE RETRACTION. PER THE QUALITY CONTROL PLAN INSPECTIONS FOR NEEDLE RETRACTION AND EXCESSIVE ADHESIVE ARE PERFORMED PERIODICALLY DURING THE MANUFACTURING PROCESS THAT MITIGATES THE OCCURRENCE OF THIS DEFECT. PREVENTATIVE MAINTENANCE (PM) WAS CONDUCTED AS SCHEDULED WITH NO DEVIATIONS. THE ROOT CAUSE IS LINKED TO THE MANUFACTURING. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED DIFFICULT NEEDLE RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382423 BATCH NO: 1032453. HAD AN RN PLACE AN IV ON A PATIENT AND THE NEEDLE DID NOT RETRACT APPROPRIATELY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: AN ADDITIONAL PHONE # WAS PROVIDED AS (B)(4). 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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED DIFFICULT NEEDLE RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382423, BATCH NO: 1032453. HAD AN RN PLACE AN IV ON A PATIENT AND THE NEEDLE DID NOT RETRACT APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022679 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ 381423 1032453 30382903814238

    Patients

    Seq Age Sex Outcome Treatment
    1