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

Model Number ABV301

Device Problem Deflation Problem (1149)

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

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

Exp date 05/2017.Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that the auto-valve in the abviser intra-abdominal pressure monitor would not deflate after 60 hours of use.The device was removed and replaced, no patient harm resulted due to the reported complaint.

Manufacturer Narrative

No previous investigations are available.A detailed, six (6) month batch record review for the associated lot was conducted and revealed that all samples subjected to the operational timing test met specifications.However, a root cause could not be determined because the auto-valve in question was not available for physical analysis.No discrepancies (including non-conformances/deviations) were found and there is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.A product sample was received however, only the diaphragm transducer section of the abviser was included.The return sample has been forwarded to the appropriate party for evaluation.Mfg date: device manufacture date corrected.The following codes were reported in error on the initial mfr#: 1049092-2016-00071 , reported to the fda on february 29, 2016: results code, conclusion code.The following codes were omitted from the initial mfr#: 1049092-2016-00071, reported to the fda on february 29, 2016 and are being corrected on this report: method code, conclusion code.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 used autovalve product sample was returned for physical analysis to determine the potential root cause.The unit was opened, and proper assembly and components were verified.The filter was cleaned and a particle was found lodged in the 0.0015" diameter laser drilled timing hole, which had prevented it from draining.Product monitoring reviews will continue to monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.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 - INTRA ABDOMINAL PRESSURE MONITOR DEVICE
• 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: 5468245
• MDR Text Key: 39311261
• Report Number: 1049092-2016-00071
• 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: 02/04/2016

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: ABV301
• Device Lot Number: 140600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/08/2016; 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2014
• 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