BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH PLUS¿ I.V. CATHETER

    MDR report key: 15387394 · Received September 8, 2022

    Report

    Report Number
    8041187-2022-00528
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 12, 2022
    Report Date
    October 10, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 24-AUG-2022 . H.6. INVESTIGATION SUMMARY: THREE SAMPLES OF BATCH 0080919 WERE RECEIVED AND LABELED AS #1 TO #3. SAMPLES 1 AND 2 WERE WITHOUT PACKAGING AND SAMPLE 3 WAS RECEIVED IN SEALED PACKAGING. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR CATHETER DAMAGE. NO CATHETER DAMAGE WAS OBSERVED ON THE SAMPLES. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. FOR THE SAMPLES OF BATCH 0080919, NO CATHETER DAMAGE WAS OBSERVED ON THE SAMPLES. THEREFORE THE REPORTED DEFECT WAS NOT CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD ANGIOCATH PLUS¿ I.V. CATHETER EXPERIENCED A TEAR. PIR44022796: SILICONE OVERFLOW IN CATHETER TUBE. PIR44022797: CATHETER TUBE IS TORN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD ANGIOCATH PLUS¿ I.V. CATHETER EXPERIENCED A TEAR. PIR44022796: SILICONE OVERFLOW IN CATHETER TUBE. PIR44022797: CATHETER TUBE IS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238620 BD ANGIOCATH PLUS¿ I.V. CATHETER INTRAVENOUS CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0080919

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown