BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH

    MDR report key: 19278987 · Received May 9, 2024

    Report

    Report Number
    9610048-2024-00050
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 16, 2024
    Report Date
    August 14, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883363
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38833614 AND POTENTIAL LOT NUMBERS 3355247 AND 4024128. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. ALTHOUGH TWO (2) PICTURES WERE PROVIDED, THE PICTURES ONLY SHOWED THE PRODUCT¿S UNIT PACKAGE INFORMATION. THEREFORE, NO FINDINGS WERE POSSIBLE FOR THE REPORTED DEFECTS THROUGH THE PICTURES. THE PHYSICAL SAMPLES WOULD BE NECESSARY TO FURTHER INVESTIGATE THIS INCIDENT. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE EVENT DATE PROVIDED IS AFTER THE COMPLAINT AWARE DATE. D. 3 POTENTIAL LOT NUMBERS PROVIDED, BUT NONE VERIFIED BY THE REPORTER AS THE AFFECTED LOT: 4024128, 3355247, AND 4024120. 4024120 IS NOT A VALID LOT NUMBER FOR THE REPORTED MATERIAL NUMBER REFLECTED IN THE COMPLAINT. E.1. CHARACTER LIMIT IS EXCEEDED: ALAMEDA TRIFON INFANTE ALGARIN 1430. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ANGIOCATH NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE JELCO TRANSFIXED BY THE NEEDLE AND CROOKED. UNSUCCESSFUL VENIPUNCTURE ATTEMPTS, WITH VENOUS TRANSFIXATION IN A 2-YEAR-OLD PATIENT, DUE TO PROBLEMS WITH THE MATERIAL DURING THE PROCEDURE, THERE WAS NO HUMAN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547534 BD ANGIOCATH PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. UNKNOWN 00382903883363

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Unknown