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

Model Number ABV320

Device Problem Connection Problem (2900)

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

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Based on the available information, no patient harm occurred.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Follow up has been requested, but no additional details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on: september 07, 2016 (b)(4).

Event Description

Complaint reported that, "in icu, one (1) adviser kit, the autovalve did not disengage and prohibited urine flow." reporter stated that "as far as she is aware there was no injury to the patient." the abviser was removed and discontinued from the patient after this occurred.The unit was discarded by the icu.No further information was available.

• Brand Name: ABVISER-INTRA ABDOMINAL PRESSURE MONITOR 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: 5934615
• MDR Text Key: 54153322
• Report Number: 1049092-2016-00388
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABV320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2016
• 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