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

Model Number ABV321

Device Problem No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).On (b)(6) 2015, the following correction was identified: the report submitted on 04-nov-2015, with the patient identifier (b)(6), had the incorrect manufacturer report number listed 1722554-2015-31257.The correct manufacturers report number should have been 1049092-2015-31257.(b)(4).

Event Description

The company representative reported urine retention with the abviser.Bladder pressure completed and within a few minutes, they noted the 20ml of flush in the urimeter.She did not see any urine in the urimeter or bag.They did bladder pressures every 6 hours for approximately 3 days so approximately 11 infusions for a total of 220ml.They performed a bladder scan and it read 300ml.They removed the abviser autovalve; reconnected the urimeter tubing and 250ml of urine drained out.The first bladder pressure was performed at 10am and a cystogram performed around noon on the same day.The technician instilled dye for cystogram in the foley catheter port.Nurse reported autovalve remains inflated even after removing it.

• Brand Name: ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 5309950
• MDR Text Key: 263398068
• Report Number: 1049092-2015-31257
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ABV321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2014
• 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
• Patient Outcome(s): Required Intervention