BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOCATH

    MDR report key: 23973190 · Received January 6, 2026

    Report

    Report Number
    9610048-2025-00198
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    September 25, 2025
    Report Date
    January 23, 2026
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883332
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38833314 AND LOT NUMBER 5051067. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, THE CATHETER WAS OBSERVED USED AND WITH A PORTION OF THE CATHETER MISSING. BASED ON THE RUPTURE CHARACTERISTICS, TAKING INTO ACCOUNT THE LOCATION AND CONDITION OF THE TUBING, IT HAS BEEN CONCLUDED THAT THE SEPARATION WAS THE RESULT OF SOME TYPE OF CUT, RATHER THAN A TENSION RELATED BREAK. WHEN THE TUBING IS RUPTURED DUE TO TENSION, STRETCHING OF THE PLASTIC MATERIAL CAN BE OBSERVED, AS IT WILL ALWAYS DEFORM BEFORE BREAKING. THIS TENSION RELATED BEHAVIOR WAS NOT OBSERVED IN THE SAMPLE PICTURES. BASED ON THE INVESTIGATION CONDUCTED, AN EXACT ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS HAS NOT BEEN DETERMINED. A PROBABLE CAUSE FOR THE COMPLAINT MAY BE RELATED TO PRODUCT USABILITY, CONSIDERING THE ABSENCE OF EVIDENCE OF PROCESS FAILURES OR SPECIFICATION DEVIATIONS IN THE LOT ANALYZED. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NURSE FROM THE PICC TEAM FROM THE HOSPITAL PERFORMED A PERIPHERAL PUNCTURE, THE CATHETER CANNULA CAME OUT WITH THE NEEDLE WHEN IT WAS REMOVED, REQUIRING MINOR SURGERY TO REMOVE THE CATHETER BODY THAT REMAINED INSIDE THE PATIENT. IMPACT TO PATIENT: PERFORMED MINOR SURGERY TO REMOVE PART OF THE CATHETER THAT REMAINED INSIDE THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32655 ANGIOCATH PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5051067 00382903883332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention