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U.S. Department of Health and Human Services

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

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CONVATEC, INC. ABVISER - INTRA ABDOMINAL PRESSURE MONITOR DEVICE; DEVICE, CYSTOMETRIC, HYDRAULIC Back to Search Results
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).
 
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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 Key5468245
MDR Text Key39311261
Report Number1049092-2016-00071
Device Sequence Number1
Product Code FEN
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 NumberABV301
Device Lot Number140600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/04/2016
Initial Date FDA Received02/29/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received04/08/2016
05/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/28/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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