BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH IV CATHETER 24GA 0.75IN

    MDR report key: 9355552 · Received November 21, 2019

    Report

    Report Number
    9610048-2019-00337
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811121
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CAPA# (B)(4) WAS INITIATED. BD RECEIVED 531 ANGIOCATH 24 GAUGE UNITS FROM LOTS 8176688, 8071883, 8180680 AND 7345853. 513 UNITS WERE RECEIVED FOR LOT 8176688, 4 UNITS WERE RECEIVED FOR LOT 8071883, 5 UNITS FOR LOT 8180680 AND 9 UNITS FOR LOT 7345853. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR ALL LOTS AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED EXCESS SILICONE ON THE CATHETERS. SILICONE WAS USED DURING THE MANUFACTURING PROCESS TO ENABLE EASIER THREADING AND RETRACTION. IT HAS BEEN TESTED AND DEEMED SAFE FOR USE. THE EXCESS SILICONE WOULD NOT CAUSE HARM OR AFFECT THE PERFORMANCE OF THE UNITS. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THE EXCESS SILICONE CAME FROM THE SILICONIZATION OF THE CATHETER TIPPING AND ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 500 BD ANGIOCATH IV CATHETER 24GA 0.75IN EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LUMPS OF SI ARE ON THE CATHETER TIPS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 500 BD ANGIOCATH IV CATHETER 24GA 0.75IN EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LUMPS OF SI ARE ON THE CATHETER TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154136 BD ANGIOCATH IV CATHETER 24GA 0.75IN INTERVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8176688 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other