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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, INC. THE ABVISER AUTOVALVE IAP MONITORING DEVICE
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CONVATEC, INC. THE ABVISER AUTOVALVE IAP MONITORING DEVICE Back to Search Results
Model Number ABV331
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The complainant reports the abviser autovalve iap monitoring device was placed for an obstruction in a pediatric patient.When the nurse attempted to infuse saline into the double check valve began to leak.The abviser was replaced.No patient complications were reported as a result of this event.
 
Manufacturer Narrative
Based on the available information, this event is deemed a reportable malfunction.The initial reporter was unable to determine the lot number of the affected product.Additional patient/event details have been requested.There were no reports of the patient being harmed as a result of this malfunction.Should additional information become available, a follow-up report will be submitted.
 
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Brand Name
THE ABVISER AUTOVALVE IAP MONITORING DEVICE
Manufacturer (Section D)
CONVATEC, INC.
211 american ave.
greensboro NC 27409
Manufacturer Contact
matthew walenciak, int assoc dir
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4908340
MDR Text Key6832032
Report Number1049092-2015-00387
Device Sequence Number1
Product Code FEN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/19/2015
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 NumberABV331
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/19/2015
Initial Date FDA Received07/09/2015
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 Number1
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