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

Model Number ABV301

Device Problem Deflation Problem (1149)

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

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

Expiration date (05/2017).Based on the available information, this event is deemed to be a reportable malfunction.No patient harm was reported.Additional details have been requested but none provided to date.The device has been returned for evaluation and was forwarded to the manufacturer for further investigation.Should additional information become available, a follow-up report will be submitted.Reported to the fda on october 06, 2016.(b)(4).

Event Description

The reporter stated, "on third day of usage (approximately 70 hours), the nurse discovered that there was no urine output from the patient.After checking all the possible reasons, the auto-valve was found not deflated." reporter stated that the device was replaced.No patient harm was reported.No further information was provided.

• 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: 6002576
• MDR Text Key: 56935523
• Report Number: 1049092-2016-00418
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• 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: 09/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2014
• 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