ABVISER AUTOVALVE IAP MONITORING DEVICE
Received Jul 9, 2015
Report 1049092-2015-00388 · MDR key 4908316
Device
Manufacturer
Convatec, Inc.Model number
ABV331Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THE ABVISER AUTOVALVE IAP MONITORING DEVICE LEAKED AT THE STOPCOCK NEAR THE TRANSDUCER. THE FACILITY WAS REPORTEDLY UTILIZING THE TRANSDUCER AND SYRINGE PROVIDED WITHIN THE ABVISER KIT. A NEW ABVISER WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
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.