VENTURI MASK KIT ADULT 120A-MM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-02-25 for VENTURI MASK KIT ADULT 120A-MM manufactured by Unomedical S.a De C.v..

Event Text Entries

[39042625] Expiration date- 04/2020. Manuf. Date- 04/2015. Based on the available information, this event is deemed to be a reportable malfunction. A return sample was not available for evaluation, therefore could not confirm a discrepancy in the product. After a detailed review of batch records for the product and lot, no discrepancies (including non-conformances/deviations) were found. The evaluation of stock samples indicated that adjustable diluter performed as intended and meets the specification requirements. There is not enough information to conclude the product did not meet specification or perform as intended. Product monitoring reviews will monitor for product trends if this issue were to reoccur. No further actions are required and the complaint will be closed. Further patient/event information was requested although no additional details have been provided to date. Should additional information become available, a follow-up report will be submitted. Reported to the fda on: february 25, 2016. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[39042626] It was reported that the "oxygen flow does not normalize as indicated. At the smallest inspired oxygen fraction, the flow is higher and the lower flow fraction increases. " no patient harm resulted due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


[40970664] Additionally, mfr report# 9680866-2016-00065 and mfr report# 9680866-2016-00066 which were submitted on 02/25/2016, are for the same patient and these complaint records are associated with each other. No additional details have been provided to date. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9680866-2016-00065
MDR Report Key5460649
Report SourceFOREIGN,USER FACILITY
Date Received2016-02-25
Date of Report2016-02-01
Date of Event2016-01-13
Date Mfgr Received2016-03-10
Date Added to Maude2016-02-25
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 FDA3
Event Location3
Manufacturer ContactMRS. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3365424681
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENTURI MASK KIT ADULT
Generic NameMASK, OXYGEN, LOW CONCENTRATION
Product CodeBYF
Date Received2016-02-25
Model Number120A-MM
Lot Number110550
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL S.A DE C.V.
Manufacturer AddressAV.:INDUSTRIAL FALCON LOTE 7 PARQUE IND, DEL NORTE REYNOSA, TAMAULIPAS 88736 MX 88736


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-25

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