ABVISER AUTOVALVE IAP MONITORING DEVICE

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO PATIENT HARM WAS REPORTED. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

COMPLAINT RECEIVED FROM A DEALER REPORTING THAT AN AUTO-VALVE MALFUNCTION HAD OCCURRED WITH THE DEVICE. REPORTER AFTER THIRTY-SIX (36) HOURS OF USAGE, THE AUTO-VALVE DID NOT OPEN WHICH RESULTED IN THE URINE AND SALINE NOT BEING ABLE TO DRAIN;THE DEVICE WAS REPLACED. THE PATIENT REQUIRED THE DEVICE FOR BLUNT ABDOMINAL TRAUMA AND HAS SINCE RECOVERED. NO FURTHER PATIENT INFORMATION, INCLUDING MEDICAL HISTORY, WAS PROVIDED.

Additional Manufacturer Narrative

A BATCH RECORD REVIEW FOR LOT# 140600 WAS PERFORMED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM), AND SHOWED THAT ALL FUNCTIONAL TESTING MET THE SPECIFICATION. THE VALVE WAS OPENED AND EVALUATED UNDER THE MICROSCOPE. IT EXHIBITED THAT THE VALVE WAS ASSEMBLED CORRECTLY. THE FILTER WAS CLEAN, BUT THE 0.0015" TIMING HOLE WAS COMPLETELY CLOGGED WITH SOME FOREIGN PARTICULATE. THE PARTICULATE WAS TOO SMALL IN SIZE TO DETERMINE THE EXACT SOURCE. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. SEVERAL PHOTOS WERE ALSO RECEIVED REGARDING THE REPORTED EVENT. 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

THIS SUPPLEMENTAL IS BEING SUBMITTED AS AN USED PRODUCT SAMPLE HAS BEEN RETURNED FOR EVALUATION. THE PRODUCT SAMPLE WAS DECONTAMINATED AND FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) 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).