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

Model Number ABV300

Device Problems Partial Blockage (1065); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

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

Event Date 07/05/2014

Event Type  malfunction  

Event Description

It is reported that the abviser device was installed to monitor iap (intra abdominal pressure) and connected to a #14 foley catheter and urine collecting bag cistoflo.The iap (intra abdominal pressure) measurement was performed for a day, however, in the measurement was performed for a day, however in the measurement of the second day at night the valve system did not deflate and collapse urine output for four (4) hours resulting in the removal of the device twenty four (24) hours of use.It is further reported that the obstruction in urine is associated with the device being in place; therefore it was decided to remove the device.

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.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.Additional quality evaluation performed on (b)(4) 2014 states that there were (b)(4) reports noted in records for urine retention, one of which was within the past year.

• Brand Name: ABVISER-INTRA ABD PRESSURE MONITOR DEVICE
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, inter assoc di ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3982689
• MDR Text Key: 4816967
• Report Number: 1049092-2014-00345
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2014

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: ABV300
• Device Catalogue Number: ABV300
• Device Lot Number: 131038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 07/24/2014
• 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