BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7060354 · Received November 27, 2017

    Report

    Report Number
    1710034-2017-00405
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 3, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814443
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION: INVESTIGATION SUMMARY: THIS LOT (7192991) PER REVIEW, IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SET-UP AND IN PROCESS SAMPLES (INCLUDING BUT NOT LIMITED TO) FOR DAMAGED COMPONENT (GRIP, BUTTON, SPRING, HUB), NEEDLE RETRACTION BY BUTTON ACTIVATION AND ADHESIVE OVERFILLED/DRIP AS WELL AS PERIODIC CLEANING/ALIGNMENT OF THE GLUE GRIPPERS WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. UNITS WERE NOT RECEIVED FOR OBSERVATION AND TESTING. INVESTIGATION CONCLUSION: CONFIRMATION OF THE DEFECT STATED IN THE PR COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED, AS THE UNIT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION AND TESTING. THEREFORE, THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECTS STATED IN THE PIR. THIS INCIDENT IS INDETERMINATE. UNABLE TO CONFIRM THE CUSTOMER¿S EXPERIENCE BECAUSE UNITS WERE NOT RETURNED FOR EVALUATION AND TESTING. UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE BECAUSE UNITS WERE NOT RETURNED FOR EVALUATION AND TESTING. ROOT CAUSE DESCRIPTION: UNITS NOT PROVIDED FOR INVESTIGATION OF THE INCIDENT STATED IN THE PR. THERE WAS NO SAMPLE AND/OR PHOTO AVAILABLE FOR EVALUATION AT THE MANUFACTURING SITE. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED WITHIN THE SCOPE OF THIS EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DURING USE. NEEDLE STICK INJURY REPORT. MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839311 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7192991 30382903814443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other