HUDSON MASK,MEDIUM CONC,ELONG,ADULT 1041

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-28 for HUDSON MASK,MEDIUM CONC,ELONG,ADULT 1041 manufactured by Teleflex Medical.

Event Text Entries

[140301684] (b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report. The device history record (dhr) of batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. Dhr shows that the product was assembled and inspected according to our specifications. Additionally, material from the production line was verified and no issues were found that can lead this customer complaint. Customer complaint cannot be confirmed based only on the information provided. To perform a proper and thorough investigation, it is necessary to evaluate the sample involved. It is noted that based on complaint trending, a capa request was initiated in order to further investigate this same issue. If the sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10


[140301685] Customer complaint alleges the device tubing came disconnected during use on a patient. There was no report of patient complication or medical intervention. Patient condition reported as fine. It was reported that an alternative product was used to resolve the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004365956-2019-00087
MDR Report Key8461187
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-28
Date of Report2019-03-21
Date of Event2019-03-14
Date Mfgr Received2019-04-12
Device Manufacturer Date2018-06-14
Date Added to Maude2019-03-28
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 FDA3
Event Location3
Manufacturer ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON MASK,MEDIUM CONC,ELONG,ADULT
Generic NameMASK, OXYGEN
Product CodeBYG
Date Received2019-03-28
Catalog Number1041
Lot Number74F1801790
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-28

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