MAUDE Adverse Event Report: CONVATEC, INC. ADVISER AUTOVALVE IAP MONITORING DEVICE WITH E

Model Number ABV321

Device Problems Partial Blockage (1065); Deflation Problem (1149)

Patient Problem Urinary Retention (2119)

Event Date 11/11/2014

Event Type  Injury  

Event Description

The critical care educator colleen ryan, registered nurse reports that the green valve in the autovalve did not deflate with one unit out of a case of 10.The registered nurse caring for the patient states that the patient was voiding around the foley catheter rather than through the catheter.The registered nurse attempted to irrigate the foley catheter and then changed the foley catheter, but the urine continued to drain around the catheter rather than through the catheter.The registered nurse removed the abviser and the urine then started to drain.

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.

• Brand Name: ADVISER AUTOVALVE IAP MONITORING DEVICE WITH E
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir. interim a ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4338159
• MDR Text Key: 21847062
• Report Number: 1049092-2014-00613
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMP;T
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABV321
• Device Lot Number: 140437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/10/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention