ABVISER® AUTOVALVE® IAP MONITORING DEVICE

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(6) 2015 (B)(6)

Description of Event or Problem

IT IS REPORTED URINE DID NOT DRAIN THROUGH THE DRAINAGE TUBING OF THE INTRA-ABDOMINAL PRESSURE MONITORING DEVICE. THE ISSUE WAS NOTED IMMEDIATELY UPON CONNECTION. THE DEVICE WAS DISCONNECTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

NO SAMPLE HAS BEEN RECEIVED. NO UNIT WAS RETURNED, SO NO PHYSICAL ANALYSIS COULD BE PERFORMED. THIRD PARTY EXAMINED THE HISTORICAL BATCH RECORDS FOR THE ABV321 MANUFACTURED FROM 05 JANUARY 2015 TO 11 JUNE 2015, INCLUDING LOT NUMBER 150616 WHICH SHOWED THAT ALL SAMPLES TESTED MET THE SPECIFICATION. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER THE DETAILED BATCH REVIEW, NO DISCREPANCIES (INCLUDING NON-CONFORMANCES/DEVIATIONS) WERE FOUND. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED, AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.