MAUDE Adverse Event Report: CONVATEC, INC. ABVISER AV IAP DEVICE, POLE MOUNT (1X10); DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABV301

Device Problem Disconnection (1171)

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

Event Date 05/28/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a malfunction.The instructions for use say to ensure the urinary catheter to valve connection is dry and then wrap a strip of tape (included in the package) around the end of the catheter to keep it snugly attached to the abviser autovalve valve.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Event Description

Information reported by a distributor indicated that the auto valve of the abviser disconnected from the foley catheter while injecting normal saline.The device had been in use for forty hours.The indication for use of the device was intestinal swelling which needed regular intra-abdominal pressure (iap) monitoring.The patient was in the supine position with the head of the bed flat when the measurement was taken,there was no resistance felt at the time of the event.It is unclear if the blue tape was provided with the kit or was applied to the connection between the auto-valve and the catheter, as this information was unavailable.The abviser was replaced with a new one; no harm was reported to the patient as a result of the disconnection.The patient's current status is being kept in surgical intensive care unit under observation.

Manufacturer Narrative

Received (1) one used abviser for evaluation.The returned product sample has been forwarded to the original equipment manufacturer for further investigation.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

A batch record review for lot# 140600 was performed by the original equipment manufacturer (oem) and showed that all functional testing met the specification.There were two sub-assembly lot#s; 140428 and 140444 used to manufacture lot# 140600.Review of lot# 140428 shows that all functional testing met specification.However, lot# 140444 did have a non-conformance related to the qa in-process flow test process.The non-conformance does not affect the overall intact of the valve (i.E.,the non-conformance is not related o the complaint issue.) a physical sample was received for this complaint, and evaluated.The used (decontaminated) product sample was returned to the oem where it was examined under a microscope.The product sample showed major cracks all around the valve cap and valve body area, which could cause the valve to detach during usage.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: ABVISER AV IAP DEVICE, POLE MOUNT (1X10)
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue, suite 400; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5730246
• MDR Text Key: 47594784
• Report Number: 1049092-2016-00282
• 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,Followup,Followup
• Report Date: 05/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• 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: 06/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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