BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19615943 · Received June 26, 2024

    Report

    Report Number
    1710034-2024-00659
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 6, 2024
    Report Date
    August 23, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814336
    PMA / PMN Number
    K201075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    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. THREE LOT NUMBERS WERE PROVIDED. IT IS UNCLEAR WHICH IS ASSOCIATED WITH THE REPORTED EVENT. BATCH # 4091427, 4072328, 3228134. E. FACILITY NAME EXCEEDS CHARACTER LIMIT: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN B5. INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH AND SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED THE TOP WEB LABEL FROM THREE LOT NUMBERS: 3228134, 4072328, AND 4091427. AS IT WAS UNABLE TO BE CONFIRMED WHICH LOT NUMBER YOUR REPORTED ISSUE OCCURRED WITH, A DEVICE HISTORY REVIEW REPORT WAS RUN ON ALL THREE. NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE WERE FOUND DURING THE PRODUCTION OF THESE BATCHES. THE PHYSICAL UNIT WAS RECEIVED WITH A NON-BD EXTENSION SET. THE IV CATHETER WAS RECEIVED IN TWO SEGMENTS AND WITH EVIDENCE OF USE. WHAT APPEARED TO BE BLOOD RESIDUE REMAINED WITHIN THE CATHETER TUBING. THE PROXIMAL SEGMENT OF CATHETER TUBING WAS STILL SECURED TO THE CATHETER ADAPTER. THE ADJOINING SURFACES OF THE CATHETER WERE MICROSCOPICALLY EXAMINED. THE CROSS SECTION EXHIBITED A GRANULAR SURFACE. A SCORE LINE WAS VISIBLE ON WHAT APPEARED TO BE THE EXTERNAL SURFACE OF THE TUBING, WHICH EXTENDED FROM ONE ADJOINING END OF THE CATHETER TOWARD THE CATHETER TIP. AS THE CONDITION OF THE PHYSICAL SAMPLE SUPPORTS YOUR DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE SAMPLE ANALYSIS. CATHETER FRACTURE MAY OCCUR AT DIFFERENT STAGES THROUGHOUT THE MANUFACTURING PROCESS OR DURING CLINICAL APPLICATION. AS THE DEVICE HAS BEEN OPENED, IT COULD NOT BE DETERMINED WITH CERTAINTY WHETHER THE DAMAGE ORIGINATED DURING MANUFACTURING OR USE OF THE DEVICE. THERE WERE NO DISTINGUISHING FEATURES WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD PNK 20GA X 1.0IN CATHETER BROKE AWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2024, A 20G IV WAS PLACED PRE-OPERATIVELY FOR AN ELECTIVE ORTHOPEDIC SURGERY. DURING SURGERY, THE IV BECAME INFILTRATED AND WAS REMOVED. UPON INSPECTION AFTER REMOVAL, THE TIP OF THE IV CATHETER WAS NOTED TO BE MISSING. THE CATHETER TIP WAS ABLE TO BE REMOVED WITH SURGICAL INTERVENTION. (B)(6) THE PATIENT REQUIRED SURGICAL REMOVAL OF THE DISTAL END OF THE CATHETER BY A HAND SURGEON, SUTURE INSERTION FOR CLOSURE, AND APPLICATION OF WOUND DRESSING. PHYSICIANS AWARE OF SITUATION. DISCLOSURE MADE TO PATIENT AND SPOUSE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: ONLY ONE PATIENT. 3 DIFFERENT LOT #¿S BECAUSE THE PACKAGE WAS NOT SAVED AND THESE LOT #¿S WERE IN THE BIN LOCATION FOR THAT AREA. COULD NOT DETERMINE THE LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654545 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903814336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention