BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE CATHETER

    MDR report key: 114699 · Received June 23, 1997

    Report

    Report Number
    114699
    Event Type
    Injury
    Date Received
    June 23, 1997
    Date of Event
    February 10, 1997
    Report Date
    February 13, 1997
    Manufacturer
    JOHNSON & JOHNSON MEDICAL INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MIDLINE INFILTRATION IN LEFT FOREARM, AREA SWOLLEN, RED, FIRM, BRUISING TO RIGHT OF THE MIDLINE BUTTERFLY WINGS. THE CATHETER SHEATH BETWEEN THE LOCKING MECHANISM AND THE LUER LOCK HUB WAS CRACKED LEAVING THE INTERNAL CATHETER MOVEABLE AND ABLE TO COME OUT OF THE LOCKING MECHANISM. THERE WAS ONE 22 GAUGE LANDMARK MIDLINE ALONG WITH AN EXTENSION SET WITH INJECTION CAP (MFR UNK) RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION USING 20X MAGNIFICATION REVEALED THAT THE LOCKING MECHANISM WAS ENGAGED AT APPROX. THE 5" MARK. THE CATHETER IS DESIGNED TO LOCK IN PLACE AT ANY LOCATION FROM 0"-6". THIS IS ACHIEVED BY SLITTING THE PROTECTIVE SHEATH FOR 6". THE CATHETER WAS NOT ABLE TO BE ADVANCED BY PULLING ON THE TAB THROUGH THE LOCK WHICH INDICATES A PROPERLY PERFORMING LOCKING MECHANISM. THERE WAS NO EVIDENCE OF ANY CRACKING OR DAMAGE TO THE LUER HUB. THE LOCKING MECHANISM BY DESIGN IS A TWO PIECE MOLDED PART. THESE PIECES WERE CONFIRMED TO BE INTACT AND FUNCTIONING NORMALLY. THE REFERENCE TO "THE CATHETER SHEATH BETWEEN THE LOCKING MECHANISM AND THE LUER LOCK HUB WAS CRACKED LEAVING THE INTERNAL CATHETER MOVEABLE AND ABLE TO COME OUT OF THE LOCKING MECHANISM" IS ACTUALLY THE SLIT OF THE PROTECTIVE SHEATH, WHICH IS SPLIT BY DESIGN. THERE WAS NO NONCONFORMANCE WITH THE CATHETER SHEATH. JOHNSON & JOHNSON MEDICAL INC., PROVIDED A LANDMARK MIDLINE CATHETER MAINTENANCE AND REFERENCE GUIDE WHICH STATES TO OBSERVE FOR BLOOD FLASHBACK BEHIND THE LOCK MECHANISM. THE INSTRUCTIONS STATE THE PROPER INSERTION TECHNIQUE. CLOSE OBSERVATION FOR FLASHBACK RESPONSE WILL INDICATE SUCCESSFUL ENTRY INTO THE VEIN. PROPER USE OF THE DEVICE WOULD HELP TO REDUCE THE INCIDENCE OF INFILTRATION. FOR BUSINESS REASONS JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE THE DISTRIBUTION OF STREAMLINE BRAND OF IV CATHETERS. THE CO WILL CONTINUE TO TRACK THIS TYPE OF INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARK MIDLINE CATHETER INDWELLING IV CATHETER FOZ JOHNSON & JOHNSON MEDICAL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention