BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON LATEX MILLER AIR TIP

    MDR report key: 4077253 · Received August 21, 2014

    Report

    Report Number
    2411512-2014-00006
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 17, 2014
    Manufacturer
    EZEM INC.
    Product Code
    FGD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY COMMENTS: A HEALTHCARE PROFESSIONAL REPORTED THAT IN 3 BARIUM ENEMA TESTS THE BALLOON FAILED TO DEFLATE WHILE REMOVING THE CATHETER. GENERALLY, DURING THIS TYPE OF EXAMINATION, A LUBRICATED ENEMA TIP IS INSERTED INTO THE PATIENT'S RECTUM. THE TIP HAS A BALLOON THAT COULD BE INFLATED JUST ENOUGH TO KEEP BARIUM FROM LEAKING OUT (OF NOTE, NOT NECESSARILY THE BALLOON SHOULD BE COMPLETELY INFLATED). AS REPORTED IN THE LABELING, THE DEFLATION OF THE BALLOON SHOULD BE STARTED AFTER COMPLETION OF FLUOROSCOPY PHASE OF THE EXAM OR AFTER THE COLON IS COMPLETELY FILLED WITH BARIUM AND SHOULD BE COMPLETED BEFORE REMOVING THE ENEMA TIP. THIS APPROACH GUARANTEES GOOD IMAGINES DURING THE EXAMINATION AND AVOIDS LESIONS IN EXTRACTING A FULLY INFLATED BALLOON. BASED ON THE ABOVE AND CONSIDERING THAT NO CLINICAL CONSEQUENCES WERE REPORTED IN THE 3 PATIENTS, THE MANUFACTURER ARGUES THAT IN THESE CASES THE BALLOON WAS AT LEAST PARTIALLY DEFLATED BEFORE REMOVING IT. IN FACT, THE REMOVAL OF A FULLY INFLATED BALLOON WOULD HAVE BEEN QUITE IMPOSSIBLE AND WOULD HAVE LED TO A DIFFICULT EXTRACTION MANEUVERS WITH TRAUMATIC LESIONS OF THE RECTUM OR ANUS. IN ANY CASE, SINCE THE INFORMATION ON MANUFACTURER'S HANDS IS VERY SCANTY, IT WAS DECIDED TO HAVE A CONSERVATIVE APPROACH AND TO REPORT THESE CASES.

    Description of Event or Problem · 1

    NARRATIVE: CASE WAS RECEIVED FROM A HOSPITAL FLUOROSCOPY AND CARDIOLOGY LEAD RADIOGRAPHER AT BRACCO (B)(4) LTD. ON (B)(4) 2014 AND FORWARDED TO (B)(4) (OPERATING ON BEHALF OF BRACCO) ON (B)(4) 2014. ON (B)(4) 2014, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PRIMARY REPORTER DIRECTLY AT (B)(4). A HEALTH PROFESSIONAL REPORTS: ON (B)(6) 2014, THERE WERE 3 INCIDENTS OF BALLOON FAILING TO DEFLATE (NON-LATEX MILLER AIR TIP, SYSTEM MODEL NO. 650012, LOT/SERIAL NO. (B)(4)) WHEN REMOVING THE CATHETER. CATHETERS NOT KEPT BUT 1.5 BAGS LEFT OF THE SAME BATCH WHICH DEPT ARE NOW RELUCTANT TO USE. NO PATIENTS HAD ANY ADVERSE CONSEQUENCES AS A RESULT OF THE BALLOON NOT DEFLATING. THE RETURN OF ONE UNUSED SAMPLE OF THE SAME BATCH FOR INVESTIGATION HAS BEEN REQUESTED. OUTCOME: RECOVERED. FURTHER INFORMATION HAS BEEN REQUESTED. WORLDWIDE CASE ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504756 NON LATEX MILLER AIR TIP CATHETER RETENTION BARIUM ENEMA WITH BAG FGD EZEM INC. 050012 50724360

    Patients

    Seq Age Sex Outcome Treatment
    1