BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABVISER AV IAP DEVICE, POLE MOUNT (1X10)

    MDR report key: 5730246 · Received June 16, 2016

    Report

    Report Number
    1049092-2016-00282
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Date of Event
    May 28, 2016
    Report Date
    May 30, 2016
    Manufacturer
    CONVATEC, INC.
    Product Code
    FEN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW FOR LOT# 140600 WAS PERFORMED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) AND SHOWED THAT ALL FUNCTIONAL TESTING MET THE SPECIFICATION. THERE WERE TWO SUB-ASSEMBLY LOT#S; 140428 AND 140444 USED TO MANUFACTURE LOT# 140600. REVIEW OF LOT# 140428 SHOWS THAT ALL FUNCTIONAL TESTING MET SPECIFICATION. HOWEVER, LOT# 140444 DID HAVE A NON-CONFORMANCE RELATED TO THE QA IN-PROCESS FLOW TEST PROCESS. THE NON-CONFORMANCE DOES NOT AFFECT THE OVERALL INTACT OF THE VALVE (I.E.,THE NON-CONFORMANCE IS NOT RELATED O THE COMPLAINT ISSUE.) A PHYSICAL SAMPLE WAS RECEIVED FOR THIS COMPLAINT, AND EVALUATED. THE USED (DECONTAMINATED) PRODUCT SAMPLE WAS RETURNED TO THE OEM WHERE IT WAS EXAMINED UNDER A MICROSCOPE. THE PRODUCT SAMPLE SHOWED MAJOR CRACKS ALL AROUND THE VALVE CAP AND VALVE BODY AREA, WHICH COULD CAUSE THE VALVE TO DETACH DURING USAGE. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    RECEIVED (1) ONE USED ABVISER FOR EVALUATION. THE RETURNED PRODUCT SAMPLE HAS BEEN FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A MALFUNCTION. THE INSTRUCTIONS FOR USE SAY TO ENSURE THE URINARY CATHETER TO VALVE CONNECTION IS DRY AND THEN WRAP A STRIP OF TAPE (INCLUDED IN THE PACKAGE) AROUND THE END OF THE CATHETER TO KEEP IT SNUGLY ATTACHED TO THE ABVISER AUTOVALVE VALVE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION REPORTED BY A DISTRIBUTOR INDICATED THAT THE AUTO VALVE OF THE ABVISER DISCONNECTED FROM THE FOLEY CATHETER WHILE INJECTING NORMAL SALINE. THE DEVICE HAD BEEN IN USE FOR FORTY HOURS. THE INDICATION FOR USE OF THE DEVICE WAS INTESTINAL SWELLING WHICH NEEDED REGULAR INTRA-ABDOMINAL PRESSURE (IAP) MONITORING. THE PATIENT WAS IN THE SUPINE POSITION WITH THE HEAD OF THE BED FLAT WHEN THE MEASUREMENT WAS TAKEN,THERE WAS NO RESISTANCE FELT AT THE TIME OF THE EVENT. IT IS UNCLEAR IF THE BLUE TAPE WAS PROVIDED WITH THE KIT OR WAS APPLIED TO THE CONNECTION BETWEEN THE AUTO-VALVE AND THE CATHETER, AS THIS INFORMATION WAS UNAVAILABLE. THE ABVISER WAS REPLACED WITH A NEW ONE; NO HARM WAS REPORTED TO THE PATIENT AS A RESULT OF THE DISCONNECTION. THE PATIENT'S CURRENT STATUS IS BEING KEPT IN SURGICAL INTENSIVE CARE UNIT UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384443 ABVISER AV IAP DEVICE, POLE MOUNT (1X10) DEVICE, CYSTOMETRIC, HYDRAULIC FEN CONVATEC, INC. ABV301 140600

    Patients

    Seq Age Sex Outcome Treatment
    1