BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 18332043 · Received December 14, 2023

    Report

    Report Number
    9610048-2023-00115
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    October 23, 2023
    Report Date
    March 21, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 3082672. 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. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. IF THE AFFECTED SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THEM. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE CATHETER BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: CATHETER WITH DULL CALIBER AND WITH POINT THAT DOES NOT PERFORATE THE SKIN OF CHILD AND NEWBORN PATIENT, CAUSING COUNTLESS UNSUCCESSFUL ATTEMPTS AND LESION DUE TO MULTIPLE PUNCTURES. ADVERSE EVENT: EDEMA IN UPPER AND LOWER LIMBS CAUSED BY INJURY. PRODUCT PRESENTS ALTERATION: YES. WHAT?: CRACK, BREAKAGE OF PRODUCT OR PART OF IT. OTHER: CATHETER WITH DULL POINT AND HARD TO PUNCTURE THE SKIN. ADDITIONAL TRANSLATION OF DOCUMENT: PROBLEM ASSOCIATED WITH AN UNWANTED SEPARATION OR A VISIBLE OPENING ALONG THE LENGTH OR WIDTH OF MATERIALS (EXAMPLES: PARTS, ASSEMBLIES, SUBASSEMBLIES OF THE PRODUCT) USED IN THE MANUFACTURE OF THE MEDICAL PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114016 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3082672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown