BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GI SUPPLY LARGE VOLUME PARACENTESIS KIT

    MDR report key: 5392822 · Received January 27, 2016

    Report

    Report Number
    2529592-2016-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Date of Event
    January 21, 2016
    Report Date
    January 25, 2016
    Manufacturer
    GI SUPPLY
    Product Code
    LRO
    PMA / PMN Number
    K970187
    Removal / Correction Number
    2529592-1/22/2016-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE OCCURRED DURING A PROCEDURE WHERE THE USER (RADIOLOGY TECH) DID NOT SEE THAT THE BAG DID NOT HAVE THE PINCH CLAMP AND WHEN SHE WENT TO CLOSE THE BAG, ABDOMINAL FLUID SPRAYED ON HER FACE. THE IFU REQUIRES YOU TO CLOSE THE CLAMP ON THE BAG PRIOR TO DETACHING THE TUBING ASSEMBLY. THE ISSUE DOES NOT AFFECT THE PERFORMANCE OF THE PRODUCT BUT COULD BE A SAFETY ISSUE FOR THE USER. THE USED FLUID COLLECTION BAG WAS DISCARDED BY THE FACILITY. THE FACILITY INDICATED THAT THE OTHER FLUID COLLECTION BAG IN THE KIT DID NOT HAVE THE CLAMP ON THE IT AND THAT THEY OPENED TWO OTHER LARGE VOLUME PARACENTESIS KITS AND THE FLUID COLLECTION BAGS IN THE KIT DID NOT HAVE THE CLAMP. EACH KIT HAS 2 FLUID COLLECTION BAGS. THE FACILITY SENT PICTURES OF 2 BAGS WITHOUT THE PINCH CLAMP AND RETURNED THOSE 2 BAGS TO GI SUPPLY. THE RETURNED FLUID COLLECTION BAGS WERE RECEIVED ON (B)(4) 2016. THE MISSING CLAMP ON EACH OF THE RETURNED FLUID COLLECTION BAG WAS VERIFIED TO BE MISSING. THE FACILITY INDICATED THEY USED AND DISCARDED THE OTHER 2 LARGE VOLUME PARACENTESIS KITS AND THEREFORE DID NOT RETURN THE KITS. FROM THE LOT (LOT 61442434), 13 RANDOM KITS WERE INSPECTED BY GI SUPPLY DURING INCOMING INSPECTION AND THIS DEFECT WAS NOT OBSERVED. ANOTHER 3 KITS WERE RANDOMLY PULLED, OPENED AND INSPECTED UPON RECEIPT OF THE COMPLAINT AND THIS DEFECT WAS NOT OBSERVED. DUE TO THE PACKAGING, THE COMPONENTS CANNOT BE VISUALLY INSPECTED WITHOUT OPENING THE STERILE PACKAGE. NO OTHER COMPLAINTS HAVE BEEN RECEIVED. THIS KIT WAS FIRST SHIPPED TO CUSTOMERS ON 03 NOVEMBER 2015.

    Description of Event or Problem · 1

    THE ISSUE WAS DISCOVERED DUE TO A CUSTOMER COMPLAINT RECEIVED ON (B)(6) 2016. THE ISSUE OCCURRED DURING A PROCEDURE WHERE THE USER (HEALTHCARE PROFESSIONAL - RADIOLOGY TECH) DID NOT SEE THAT THE FLUID COLLECTION BAG FROM THE LARGE VOLUME PARACENTESIS KIT DID NOT HAVE THE PINCH CLAMP. WHEN THE USER WENT TO CLOSE THE BAG AND DETACH THE BAG FROM THE TUBING ASSEMBLY, ABDOMINAL FLUID SPRAYED ON HER FACE. THE INSTRUCTIONS FOR USE (IFU) REQUIRES YOU TO CLOSE THE CLAMP ON THE BAG PRIOR TO DETACHING THE TUBING ASSEMBLY AND REMOVING THE BAG. NO ALTERNATIVE MEANS WERE USED TO CLAMP THE BAG. THE USER (HEALTHCARE PROFESSIONAL - RADIOLOGY TECH) WAS TREATED IN THE ER AND THIS WAS TREATED AS A BLOOD AND BODY FLUID EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52937 GI SUPPLY LARGE VOLUME PARACENTESIS KIT PARACENTESIS KIT LRO GI SUPPLY 61442434

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other