BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 8147057 · Received December 10, 2018

    Report

    Report Number
    9610048-2018-00216
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    July 17, 2018
    Report Date
    January 14, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883332
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY #004712BJF LOT 7241708 MANUFACTURED FROM 06-SEP-17 TO 29-SEP-17 ACAM 1 MACHINE UNDER USED IN CLAIMED LOT 7241864. THIS LOT WAS REVIEWED REGARDING THE TESTS OF ¿FOREIGN MATTER/ VISIBLE SILICONE¿ AND WERE NOT EVIDENCED RECORDS THAT COULD LEAD TO THE CLAIMED DEFECT. CONCLUSION(S): NOT CONFIRMED: BD WAS UNABLE TO CONFIRM THE CUSTOMER COMPLAINT FOR THE CLAIMED DEFECT. AS NO PHOTOS OR SAMPLES RETURNED FROM THE CLIENT WERE RECEIVED FOR ANALYSIS, THE PRESENCE OF FOREIGN MATTER/ VISIBLE SILICONE IN THE CATHETER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ANGIOCATH¿ IV CATHETER HAD LUMPS OF SILICON THAT COATED THE NEEDLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BD ANGIOCATH¿ IV CATHETER HAD LUMPS OF SILICON THAT COATED THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988629 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7241864 00382903883332

    Patients

    Seq Age Sex Outcome Treatment
    1 Other