ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO PATIENT HARM WAS REPORTED. ONE ABVISER WAS RECEIVED ATTACHED TO A SALINE BAG FOR EVALUATION. THE SALINE BAG WAS DISCARDED. THE DEVICE WAS DECONTAMINATED WITH 10% BLEACH WATER AND THOROUGHLY DRIED. THE DEVICE WAS FORWARDED TO THE THIRD PARTY SUPPLIER FOR EVALUATION. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME 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 STATED "ON THIRD DAY OF USAGE, THE AUTO-VALVE DID NOT OPEN. IT RESULTED IN THE URINE AND SALINE COULD NOT BE DRAINED." REPORTER STATED THAT THE DEVICE WAS REPLACED. NO PATIENT INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE BATCH RECORD FOR ABV301, LOT# 141133 WAS REVIEWED BY THE MANUFACTURER AND SHOWED THAT ALL FUNCTIONAL TESTING MET THE SPECIFICATION AND INDICATES NO DISCREPANCIES RELATED TO THE COMPLAINT ISSUE. THERE WAS A DEVIATION ISSUED TO THE BATCH RECORD, DUE TO THE REPLACING OF SALINE WITH DISTILLED WATER DURING POST STERILE FUNCTIONAL TESTING. THE DEVIATION HAS NO EFFECT ON THE PRODUCT COMPLAINT. THE SUB-ASSEMBLY BATCH RECORDS USED FOR BUILDING ABV301 WERE REVIEWED BY THE MANUFACTURER AND NO ISSUE WERE FOUND. A PHOTOGRAPH AND PHYSICAL SAMPLE HAVE BEEN RECEIVED FOR EVALUATION. THE VALVE WAS OPENED AND EVALUATED UNDER THE MICROSCOPE AND EXHIBITED THAT THE VALVE ASSEMBLY HAD A MISSING MICRO FILTER COMPONENT. THE MICRO FILTER MAIN PURPOSE IS TO PREVENT ANY PARTICULATES FROM OCCLUDING THE 0.0015" DIAMETER LASER DRILLED TIMING HOLE. THE LASER DRILLED TIMING HOLE WAS FOUND OCCLUDED WITH FOREIGN PARTICULATE INSIDE. 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. REPORTED TO THE FDA ON SEPTEMBER 28, 2016. (B)(4).