ABVISER-INTRA ABDOMINCAL PRESSURE MONITOR
Received Feb 12, 2014 · Event occurred Jan 22, 2014
Report 2243969-2014-00037 · MDR key 3802018
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec Inc.Model number
ABV301Catalog number
ABV301
Lot number
11003D
Product problems
- Device Slipped
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
INFORMATION RECEIVED VIA COMPLAINT FORM IS INDICATING AS FOLLOWS: "THE AUTOVALVE WAS POPOUT DURING FLUSHING FOR PRIME".
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. AN EMAIL REQUEST WAS SENT ON (B)(4) 2014 REQUESTED NAME OF COMPLAINANT. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO IT'S COMPLAINT HANDLING AND CAPA PROCEDURES. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014.