MAUDE Adverse Event Report: CONVATEC, INC. ABVISER-INTRA ABDOMINAL PRESSURE MONITOR; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABV321

Device Problem Deflation Problem (1149)

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

Event Date 09/17/2014

Event Type  malfunction  

Event Description

It is reported that after nine (9) days of placement of the device on a pt from the icu, insufflation with 20cc of saline solution was performed.Although the measure of the intra-abdominal pressure was taken correctly, the automatic valve did not collapse.

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.The physician waited for some minutes and decided to remove the device since the pt was not in a critical state.The device was discarded and upon revision the day after, the valve was still distended.An investigation was performed by the third party manufacturing site that included a historical review of the batch records for the past six months to date of manufacture of the complaint lot.All the testings met specification and performance requirements.No root cause was determined since the device had been discarded.No add'l pt/event details have been provided to date.A return sample for eval is not expected.Should add'l info become available, a f/u report will be submitted.

• Brand Name: ABVISER-INTRA ABDOMINAL PRESSURE MONITOR
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, assoc. dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4181171
• MDR Text Key: 5022644
• Report Number: 1049092-2014-00517
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2016
• Device Model Number: ABV321
• Device Catalogue Number: ABV321
• Device Lot Number: 130217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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