THE ABVISER AUTOVALVE IAP MONITORING DEVICE
Received Jul 9, 2015
Report 1049092-2015-00387 · MDR key 4908340
Device
Manufacturer
Convatec, Inc.Model number
ABV331Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THE INITIAL REPORTER WAS UNABLE TO DETERMINE THE LOT NUMBER OF THE AFFECTED PRODUCT. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE COMPLAINANT REPORTS THE ABVISER AUTOVALVE IAP MONITORING DEVICE WAS PLACED FOR AN OBSTRUCTION IN A PEDIATRIC PATIENT. WHEN THE NURSE ATTEMPTED TO INFUSE SALINE INTO THE DOUBLE CHECK VALVE BEGAN TO LEAK. THE ABVISER WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.