ABVISER-INTRA ABD PRESSURE MONITOR DEVICE
Received Jul 7, 2014 · Event occurred Jun 11, 2014
Report 1049092-2014-00272 · MDR key 4012684
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec Inc.Model number
ABV301Catalog number
ABV301
Lot number
11003D
Product problems
- Defective Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL QUALITY INFO RECEIVED ON (B)(4) 2014 STATES THAT THERE WERE SIX (6) REPORTED COMPLAINTS APPEARED TO BE RELATED TO THE AUTOVALVE. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.
Description of Event or Problem
IT IS REPORTED THAT AFTER INJECTION, FOR A WHILE THE AUTO VALVE WAS STILL CLOSED AND COULD NOT BE OPENED AUTOMATICALLY RESULTING IN THE DEVICE BEING REMOVED BECAUSE IT COULD NOT BE USED IN THE PT.