BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC CATHETER

    MDR report key: 12965108 · Received December 8, 2021

    Report

    Report Number
    1710034-2021-01038
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 5, 2021
    Report Date
    November 23, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826378
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. THE PHOTO DISPLAYED THE LABELS OF TWO PACKAGES FROM MATERIAL #382637, LOT #0190042. VISUAL OBSERVATION OF THE PHOTO REVEALED THERE WAS NO VIEW OF A DEVICE FOR INVESTIGATION. UNFORTUNATELY, THE PHOTO PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE. ADDITIONAL INSPECTIONS OR INVESTIGATION INTO THE REPORTED DEFECT COULD NOT BE PERFORMED WITHOUT THE PHYSICAL SAMPLE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND THIS WAS THE FIRST OCCURRENCE OF THIS FAILURE MODE. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. THE PHOTO DISPLAYED THE LABELS OF TWO PACKAGES FROM MATERIAL #382637, LOT #0190042. VISUAL OBSERVATION OF THE PHOTO REVEALED THERE WAS NO VIEW OF A DEVICE FOR INVESTIGATION. UNFORTUNATELY, THE PHOTO PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE. ADDITIONAL INSPECTIONS OR INVESTIGATION INTO THE REPORTED DEFECT COULD NOT BE PERFORMED WITHOUT THE PHYSICAL SAMPLE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND THIS WAS THE FIRST OCCURRENCE OF THIS FAILURE MODE. 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 WHILE USING A BD INSYTE¿ AUTOGUARD¿ BC CATHETER THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT OR USER IMPACT.   THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, NEEDLE DID NOT RETRACT INTO THE HOUSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD INSYTE¿ AUTOGUARD¿ BC CATHETER THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT OR USER IMPACT.   THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, NEEDLE DID NOT RETRACT INTO THE HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858786 BD INSYTE¿ AUTOGUARD¿ BC CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382637 0190042 30382903826378

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown