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

Model Number ABV301

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 01/22/2014

Event Type  malfunction  

Event Description

Information received via complaint form is indicating as follows: "the autovalve was popout during flushing for prime".

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.An email request was sent on (b)(4) 2014 requested name of complainant.Convatec will continue to track and monitor such complaints according to it's complaint handling and capa procedures.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information becomes available, a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.

• Brand Name: ABVISER-INTRA ABDOMINCAL PRESSURE MONITOR
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC INC.; 200 headquarters park dr.; skillman NJ 08558
• Manufacturer Contact: mary szaro, associate director ; 200 headquarters park dr.; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3802018
• MDR Text Key: 4528815
• Report Number: 2243969-2014-00037
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2014

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 Model Number: ABV301
• Device Catalogue Number: ABV301
• Device Lot Number: 11003D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1