ABVISER AUTOVALVE IAP MONITORING DEVICE
Received Feb 29, 2016 · Event occurred Feb 2, 2016
Report 1049092-2016-00070 · MDR key 5468465
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec Inc.Model number
ABV301Lot number
140600
Product problems
- Break
- Disconnection
- Detachment of Device or Device Component
- Break
- Disconnection
- Detachment of Device or Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A BATCH RECORD REVIEW INDICATED A DISCREPANCY IN ONE OF THE SUBASSEMBLY LOTS (# 140444) FOR A HIGH FLOW IN THE QA IN-PROCESS FLOW TEST WHICH WAS NOT RELATED TO THIS COMPLAINT FAILURE. SUB-LOT # 140444 WAS SUBJECTED TO 100% TESTING PRIOR TO RELEASE. NO ADDITIONAL INVESTIGATION IS NEEDED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT 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. (B)(4).
Additional Manufacturer Narrative
ON (B)(6) 2017. (B)(6). ON (B)(6) 2014. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT INFORMATION WAS PROVIDED. 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
IT WAS REPORTED THAT AFTER SIX (6) HOURS OF USAGE, THE AUTO-VALVE WAS DETACHED WHEN INJECTING NORMAL SALINE. A PICTURE WAS ALSO RECEIVED DEPICTING THE REPORTED COMPLAINT ISSUE.
Additional Manufacturer Narrative
NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. A DETAILED, SIX (6) MONTH BATCH RECORD REVIEW FOR THE ASSOCIATED LOT WAS CONDUCTED AND REVEALED THAT ALL SAMPLES SUBJECTED TO THE OPERATIONAL TIMING TEST MET SPECIFICATIONS. HOWEVER, A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE AUTO-VALVE IN QUESTION WAS NOT AVAILABLE FOR PHYSICAL ANALYSIS. NO DISCREPANCIES (INCLUDING NON-CONFORMANCES/DEVIATIONS) WERE FOUND AND THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. A PRODUCT SAMPLE WAS RECEIVED HOWEVER, ONLY THE DIAPHRAGM TRANSDUCER SECTION OF THE ABVISER WAS INCLUDED. THE RETURN SAMPLE HAS BEEN FORWARDED TO THE APPROPRIATE PARTY FOR EVALUATION. (B)(4). NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).