BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRO SPLITTABLE 28GA NEEDLE

    MDR report key: 3667197 · Received February 20, 2014

    Report

    Report Number
    1625425-2014-00005
    Event Type
    Death
    Date Received
    February 20, 2014
    Date of Event
    January 8, 2014
    Report Date
    February 20, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    LJS
    PMA / PMN Number
    K920755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS A PREMATURE (B)(6) OLD BABY WHO WAS SEPTIC WITH (B)(6). BASED ON ADDITIONAL INFO RECEIVED, THE FOLLOWING IS THE SEQUENCE OF EVENTS: THE FIRST INTRODUCER DID NOT BREAK PROPERLY. HOWEVER, THE HEALTH CARE PROVIDERS WERE ABLE TO GET A CATHETER IN. TWO TO THREE HOURS LATER, THE LINE OCCLUDED. THE LINE WAS HEP-LOCKED WHICH MAY CAUSE THE LINE TO OCCLUDE. THE HOSPITAL DECIDED TO REPLACE THE FIRST INTRODUCER WITH A SECOND INTRODUCER. THE SECOND INTRODUCER ALSO DID NOT BREAK PROPERLY AND THEY PULLED THE SECOND LINE. A THIRD ATTEMPT WAS MADE. THE INTRODUCER DID NOT BREAK WITH SNAPPING; HOWEVER, THEY WERE ABLE TO GET IT TO BREAK WITH HEMOSTATS AND GOT THE LINE IN. THE LINE WAS INFUSING AND OCCLUDED LATER. THE BABY PASSED AFTERWARDS. TWO FAILURE MODES WERE NOTED; CRACKING/SPLITTING FOR THE NEEDLES AND OCCLUSION OF THE CATHETERS. THE COMPLAINT SPLITTABLE NEEDLE WAS NOT RETURNED FOR ANALYSIS AND NO SAMPLES FROM THE COMPLAINT LOT WERE AVAILABLE FOR EVAL. THE LOT NUMBER PROVIDED WAS NOT A VALID LOT NUMBER FOR SPLITTABLE NEEDLES; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. THE LOT NUMBER AND THE ASSOCIATED LOWER LEVEL LOT NUMBERS FOR THE CATHETER WERE REVIEWED FOR ANY ISSUES ASSOCIATED WITH THE OCCLUSION ISSUE AND NO ISSUES WERE NOTED IN THE HISTORICAL FILES. PER THE RISK MGMT DOCUMENTATION AND THE CLINICAL MANUAL, THE MAJORITY OF CATHETER OCCLUSIONS ARE BELIEVED TO BE DUE TO FIBRIN ACCUMULATION OR CLOT FORMATION. OCCLUSION CAN OCCUR WHEN NON-COMPATIBLE MEDICINES ARE INFUSED TOGETHER OR INFUSED RIGHT AFTER ANOTHER WITHOUT PROPER FLUSHING BETWEEN MEDICINE DELIVERIES. WHEN THE EDC IS KEPT AS A HEPARIN LOCK, MAINTAINING PATENCY IS DEPENDENT UP THE PROPER FLUSHING TECHNIQUE. INSTRUCTIONS FOR ASPIRATION AND FLUSHING IS PROVIDED IN SECTION 10 OF THE IFU. CATHETERS GO THROUGH 100% VISUAL INSPECTION AS WELL AS FUNCTIONAL TESTS TO DETECT ANY ISSUES. NO CORRELATIONS WERE ESTABLISHED WITH THE SPLITTING/CRACKING OF THE NEEDLES OR THE OCCLUSION OR THE CATHETERS WITH THE DEATH OF THE BABY. BASED ON INFO RECEIVED, THE HOSPITAL IS NOT SAYING THAT THE INTRODUCER CAUSED THE DEATH OF THE BABY.

    Description of Event or Problem · 1

    INSERTION OF THE CATHETERS WERE ATTEMPTED ON THE BABY THREE DIFFERENT TIMES. FAILURES OF THE FIRST TWO NEEDLES WERE DUE TO SPLITTING/CRACKING. THE THIRD ATTEMPT WAS SUCCESSFUL. ALL OF THESE INTRODUCERS WERE REPORTED TO HAVE DIFFICULTY IN SPLITTING OR WERE CRACKED. DEATH OCCURRED ON (B)(6) 2014. PRODUCT REMAINED INDWELLING AT TIME OF DEATH AND IS WITH PT. SEPSIS WAS NOTED AROUND (B)(6) 2014 ((B)(6)) AND DEATH FOLLOWED. PRODUCT REMAINED INDWELLING AT TIME OF DEATH OF THE PT. NOTE: THE LOT NUMBER PROVIDED WAS NOT A VALID LOT NUMBER FOR THE SPLITTABLE NEEDLE. IT WAS THE LOT NUMBER (11050344) FOR THE CATHETER. NO PRODUCT FROM THIS LOT WAS FOUND IN STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106614 INTRO SPLITTABLE 28GA NEEDLE INTRODUCER LJS ARGON MEDICAL DEVICES INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Death