OXYGEN & AEROSOL THERAPY 1003MMUE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-04-29 for OXYGEN & AEROSOL THERAPY 1003MMUE manufactured by Convatec Limited.

Event Text Entries

[4455582] It is reported that the hole in the valve is too small preventing the correct flow rate of air to pass through the venturi valve.
Patient Sequence No: 1, Text Type: D, B5


[12044959] Based on the available info, this event is deemed a reportable malfunction. There were no reports of the pt being harmed as a result of this malfunction. Investigation performed on (b)(4) 2011 by (b)(4) based on the eval of sample rec'd are as follows: "following the results of the o2% testing we were satisfied that the jet was not functionally unsafe; however, we needed to ascertain why we were getting partially blocked jets. A through examination under magnification of the moulding tool revealed some damage to one of the mould cavities. This was not visible to the naked eye. This damage must have occurred shortly before or during the run that produced the jets used in this batch as the mfg records from previous batches did not show any abnormalities and there have been no adverse incidents reported since the moulding tool was repaired in (b)(4) 2010. The mfg records for this batch did not show any marked abnormalities either but the qc inspection looks for o2% and partially blocked jets do still produce 28% o2. Our tool maker has not looked at the tool and has suggested a modification to prevent further incidents of this nature. We have agreed with his proposal and the toolmaker is now making the modification which will then be validated before any further 28% jets are released into production. " note: this mdr is being reported as a result of a retrospective review of complaints conducted by convatec for complaints rec'd from (b)(6) 2011 - (b)(6) 2013. Convatec will continue to track and monitor such complaints according to convatec inc's. Complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1000317571-2014-00024
MDR Report Key3869081
Report Source01,05,06,07
Date Received2014-04-29
Date of Report2011-05-05
Date of Event2011-05-05
Date Mfgr Received2011-05-05
Date Added to Maude2014-06-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMATTHEW WALENCIAK, INTERIM ASSOCI
Manufacturer Street200 HEADQUARTERS PARK DRIVE
Manufacturer CitySKILLMAN NJ 08558
Manufacturer CountryUS
Manufacturer Postal08558
Manufacturer Phone9083779293
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOXYGEN & AEROSOL THERAPY
Generic NameMASK, O2 LOW CONCENTRATION, VENTURI
Product CodeBYF
Date Received2014-04-29
Returned To Mfg2011-05-16
Model Number1003MMUE
Catalog Number1003MMUE
Lot Number3120441
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC LIMITED
Manufacturer AddressFIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH5 2NU


Patients

Patient NumberTreatmentOutcomeDate
10 2014-04-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.