ABVISER AUTOVALVE IAP MONITORING DEVICE ABV331

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-09 for ABVISER AUTOVALVE IAP MONITORING DEVICE ABV331 manufactured by Convatec,inc..

Event Text Entries

[6832512] It was reported the abviser autovalve iap monitoring device leaked at the stopcock near the transducer. The facility was reportedly utilizing the transducer and syringe provided within the abviser kit. A new abviser was used. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[14209281] 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, af follow-up report will be submitted. See scanned page.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1049092-2015-00389
MDR Report Key4908315
Report Source06
Date Received2015-07-09
Date of Report2001-06-19
Date Mfgr Received2015-06-19
Device Manufacturer Date2015-01-01
Date Added to Maude2015-07-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMATTHEW WALENCIAK, INT ASSOC DIR
Manufacturer Street211 AMERICAN AVE.
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone9083779293
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABVISER AUTOVALVE IAP MONITORING DEVICE
Product CodeFEN
Date Received2015-07-09
Model NumberABV331
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC,INC.
Manufacturer Address211 AMERICAN AVE. GREENSBORO NC 27409 US 27409


Patients

Patient NumberTreatmentOutcomeDate
1140900 2015-07-09

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