BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 11285622 · Received February 5, 2021

    Report

    Report Number
    1710034-2021-00094
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 13, 2021
    Report Date
    March 24, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815333
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/8/2021. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED TWO TOP LABELS, A RETRACTED NEEDLE ASSEMBLY, ONE USED CATHETER ADAPTER ASSEMBLY AND A NEEDLE COVER FOR INVESTIGATION. DURING THE VISUAL/MICROSCOPIC EXAMINATION OF THE CATHETER ADAPTER ASSEMBLY, IT WAS OBSERVED THAT THE OUTER THREADS AT THE BASE OF THE ADAPTER WERE DAMAGED. AN ATTEMPT WAS MADE TO CONNECT THE LUER TO A CONNECTION DEVICE, BUT A CONNECTION COULD NOT BE MADE. THE DEFECT OF ADAPTER/ CONNECTOR DEFECTIVE/ DAMAGED WAS CONFIRMED. DAMAGE TO THE THREADS CAN OCCUR DURING THE MANUFACTURING PROCESS AND ARE LIKELY DUE TO MISALIGNMENT. THE CATHETER TUBING AND NEEDLE COVER WERE ALSO INSPECTED FOR DAMAGE BUT NO DAMAGE WAS OBSERVED. BD WAS UNABLE TO CONFIRM THE REPORTED DEFECT A ¿BLEB ON THE CANNULA END¿. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED A NEEDLE THROUGH CATHETER AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381533 BATCH NO: 0230741. WE ARE CONTINUING TO SEE PROBLEMS WITH OUR NEXIVA IV CATHETERS. I HAVE HAD TWO MORE INCIDENTS TODAY, TWO PRODUCTS BUT STILL CONTINUING TO HAVE PROBLEMS. DEFECTIVE IV CANNULA. BLEB ON CANNULA END AND INJECTION CAP WOULD NOT SCREW ON THE END OF THE CANNULA. REQUIRE NEW IV TO BE PLACED. WE HAVE HAD MULTIPLE OTHER INCIDENTS WITH BD PRODUCTS RECENTLY WITH THE IV NEEDLES STICKING STRAIGHT OUT OF THE SIDE OF THE PLASTIC PROTECTOR.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED A NEEDLE THROUGH CATHETER AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381533, BATCH NO: 0230741. WE ARE CONTINUING TO SEE PROBLEMS WITH OUR NEXIVA IV CATHETERS. I HAVE HAD TWO MORE INCIDENTS TODAY, TWO PRODUCTS BUT STILL CONTINUING TO HAVE PROBLEMS. DEFECTIVE IV CANNULA. BLEB ON CANNULA END AND INJECTION CAP WOULD NOT SCREW ON THE END OF THE CANNULA. REQUIRE NEW IV TO BE PLACED. WE HAVE HAD MULTIPLE OTHER INCIDENTS WITH BD PRODUCTS RECENTLY WITH THE IV NEEDLES STICKING STRAIGHT OUT OF THE SIDE OF THE PLASTIC PROTECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182027 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0230741 00382903815333

    Patients

    Seq Age Sex Outcome Treatment
    1