MAUDE Adverse Event Report: CONVATEC INC. ABVISER AUTOVALVE IAP MONITORING DEVICE; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABV301

Device Problems Break (1069); Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2016

Event Type  malfunction  

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).

Event Description

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.

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).

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).

• Brand Name: ABVISER AUTOVALVE IAP MONITORING DEVICE
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5468465
• MDR Text Key: 39308991
• Report Number: 1049092-2016-00070
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABV301
• Device Lot Number: 140600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1