BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH IV CATHETER

    MDR report key: 10399847 · Received August 12, 2020

    Report

    Report Number
    9610048-2020-00117
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 17, 2020
    Report Date
    July 31, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811374
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF ADAPTER/CONNECTOR DEFECTIVE/DAMAGED WITH LOT #8270883, REGARDING ITEM #381137. AN ANALYSIS OF THE BATCH HISTORY OF THE DEVICE HAS BEEN COMPLETED FOR THE SUB-ASSEMBLY 008664BJF, BATCH 8242502 MANUFACTURED FROM 13-SEPTEMBER-2018 TO 28-SEPTEMBER-2018 ON THE ACAM #04 MACHINE USED IN THE CLAIMED BATCH # 8270883. THIS BATCH WAS REVISED WITH RESPECT TO THE ¿DAMAGED COMPONENT¿, ¿LEAKAGE¿ TESTS AND NO RECORDS WERE FOUND THAT COULD LEAD TO THE CLAIMED DEFECT. THIS COMPLAINT DOES NOT CONTAIN A PHOTO OR SAMPLES FOR ANALYSIS. ROOT CAUSE DESCRIPTION: BASED ON THE RESULTS OF THE INVESTIGATION TO DATE, IT HAS NOT BEEN POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE CLAIMED DEFECT. RATIONALE: BASED ON THIS, A CAPA IS NOT NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADAPTER WAS BROKEN DURING USE WITH A BD ANGIOCATH¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CONNECTION BETWEEN THE NEEDLE HANDLE AND THE NEEDLE WAS BROKEN DURING THE USE OF THE DEPARTMENT OF CRITICAL CARE MEDICINE (EXTRACARDIAC), CAUSING ARTERIAL LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864025 BD ANGIOCATH IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381137 8270883 30382903811374

    Patients

    Seq Age Sex Outcome Treatment
    1 Other