ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE
Received Apr 22, 2016 · Event occurred Mar 24, 2016
Report 1049092-2016-00182 · MDR key 5600751
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec Inc.Model number
ABV301Lot number
130428
Product problems
- Sticking
- Defective Component
- Sticking
- Defective Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE MANUFACTURE DATE: 05/2016. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. BASED ON THE AVAILABLE INFORMATION, NO PATIENT HARM OCCURRED. FOLLOW UP HAS BEEN REQUESTED, BUT NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem
REPORTER STATED "THE AUTO-VALVE WAS STUCK AND DID NOT WORK." REPORTER STATED THAT THE DEVICE HAD BEEN IN USE FOR FIVE (5) DAYS WHEN THE ISSUE OCCURRED. REPORTER PROVIDED NO FURTHER DETAILS.
Additional Manufacturer Narrative
(EXPIRATION DATE) 09/2016. THE BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. THE BATCH RECORDS MANUFACTURED FROM DECEMBER 1, 2012 THROUGH MAY 31, 2013 (INCLUDING LOT# 130428), SHOWED ALL FUNCTIONAL TESTING MET THE SPECIFICATIONS. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/ EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON JUNE 09, 2016.