BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA II¿ IV CATHETER 24 G X 0.75 IN.

    MDR report key: 6344401 · Received February 20, 2017

    Report

    Report Number
    3006948883-2017-00005
    Event Type
    Injury
    Date Received
    February 20, 2017
    Date of Event
    January 25, 2017
    Report Date
    April 10, 2017
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE POTENTIAL LOT NUMBERS 6204287 & 6230071. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: THE EXACT LOT NUMBER INVOLVED IN THIS INCIDENT IS UNKNOWN. THE CUSTOMER DID TWO PROVIDE THE FOLLOWING TWO POTENTIAL LOT NUMBERS: LOT 6204287 - EXPIRATION DATE 08/31/2019, MANUFACTURE DATE 07/22/2016. LOT 6230071 - EXPIRATION DATE 09/30/2019, MANUFACTURE DATE 08/17/2016. UDI # (B)(4). DEVICE EVALUATION: A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE SUSPECT DEVICE PLACED ON THE AFTERNOON OF (B)(6) 2017 TO THE PATIENT'S HAND. NOTHING ABNORMAL WAS NOTED DURING INSERTION. NO ABNORMALITIES WERE NOTED DURING THE INFUSIONS BETWEEN PLACEMENT TO (B)(6). THE NURSE FLUSHED THE EXTENSION TUBING WITH A BD FLUSH AND STARTED THE INFUSION AT THE INFUSION OPERATION STATION. NOTHING ABNORMAL WAS NOTED AT THIS STAGE. JUST AFTER THE PATIENT RETURNED TO HIS/HER SEAT, THE SOLUTION LEAKED AND CAUSED THE DRESSING TO REMOVE FROM THE IV SITE. THE NURSE WENT TO REMOVE THE SUSPECT DEVICE AND NOTICED THE CATHETER WAS BROKEN, WITH 0.5 CM LEFT ON THE TUBE AND THE REST OF THE CATHETER MISSING. THE PATIENT HAD A B-MODE ULTRASOUND TO THE HAND AND THE DOCTOR NOTED AN APPROXIMATELY 0.5 CM SHADOW UNDER THE MUSCULAR LAYER BUT NOT IN THE BLOOD VESSEL. THE DOCTOR COULD NOT CONFIRM IT AS A BROKEN CATHETER AND SUGGESTED TO "OBSERVE THE PATIENT'S HEALTH CONDITION FIRST". NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS TAKEN. AS OF (B)(6), NO INFORMATION HAD BEEN RECEIVED REGARDING WORSENING PATIENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125227 BD INTIMA II¿ IV CATHETER 24 G X 0.75 IN. INTRAVASCULAR CATHETER FOZ BD (SUZHOU) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention