BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 24809233 · Received April 7, 2026

    Report

    Report Number
    3003674698-2026-01229
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 7, 2026
    Manufacturer
    MEDSOURCE LABS LLC
    Product Code
    FOZ
    UDI-DI
    10612479267548
    PMA / PMN Number
    K150611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH MANUFACTURING RECORDS: THE BATCH MANUFACTURING RECORDS (BMR) FOR THE REPORTED BATCH WERE REVIEWED. NO NON-CONFORMITIES RELATED TO THE COMPLAINT WERE OBSERVED IN THE REPORTS. SUPPLIER VERIFICATION: REPORTS WERE VERIFIED FOR ANY SUPPLIER CHANGES OR RAW MATERIAL CHANGES. NO CHANGES WERE INCORPORATED IN THE PROCESS OR MATERIALS. CONTROL SAMPLES: NO NON-CONFORMITIES RELATED TO THE REPORTED COMPLAINT WERE OBSERVED DURING THE VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE CONTROL SAMPLES OF THE SLIDING SAFETY IV CATHETER. THE FOLLOWING TESTS WERE PERFORMED ON THE CONTROL SAMPLES TO INVESTIGATE THE REPORTED COMPLAINT: VISUAL INSPECTION: NO VISUAL DEFECTS OBSERVED IN THE PRODUCT. PULL TEST OF THE CATHETER: OBSERVED WITHIN THE SPECIFICATION. LEAKAGE TEST: NO LEAKAGE OBSERVED IN THE PRODUCT. POSSIBLE ROOT CAUSES PER PRODUCTION TEAM: USER ERROR: THE DEVICE MAY NOT HAVE BEEN USED AS INTENDED BY THE MANUFACTURER. THE CATHETER MAY HAVE BEEN DAMAGED OR DEFORMED DUE TO MULTIPLE INSERTION ATTEMPTS BY THE END USER. THE CATHETER MIGHT HAVE BEEN PULLED OR TWISTED EXCESSIVELY DURING OR AFTER INSERTION. CONCLUSION: BASED ON THE ROOT CAUSE ANALYSIS AND THE RESULTS OBTAINED FROM THE TESTS CARRIED OUT ON THE CONTROL SAMPLES OF THE REPORTED BATCH, IT IS CONCLUDED THAT THE PRODUCT DOES NOT CONTAIN A MANUFACTURING DEFECT. THE MOST LIKELY CAUSE IS USER-RELATED, SUCH AS IMPROPER HANDLING OR EXCESSIVE MECHANICAL STRESS DURING USE. THE PRODUCT MEETS THE SPECIFIED REQUIREMENTS WHILE TESTED.

    Description of Event or Problem · 0

    PLASTIC CLEAR TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT. AFTER THE INCIDENT, THE NURSE HAD TO APPLY PRESSURE TO MILK THE CATHETER OUT OF THE PATIENT'S VEIN. SHE THEN PROCEEDED TO START ANOTHER IV. THE CATHETER TIP BROKE OFF THE RIDGED CATHETER HUB. NO MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865529 MCKESSON BRANDS MCKESSON SLIDE STYLE SAFETY IV CATHETER 22G X 1" FOZ MEDSOURCE LABS LLC 200-IVS221 50841/0586 10612479267548

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown