HUDSON ONE WAY VALVE, FEMALE TO MALE 1665

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 2014-02-05 for HUDSON ONE WAY VALVE, FEMALE TO MALE 1665 manufactured by Teleflex Medical.

Event Text Entries

[4465860] The complaint was reported as: the customer alleges that the resistance in the one way valve is too great. The reported issue detected during testing set-up.
Patient Sequence No: 1, Text Type: D, B5


[11766091] A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned. A record review of the device history record (dhr) showed that there were no issues related to this complaint neither on the product nor its components during the manufacture of the material. A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident. The customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident. If the defective sample becomes available this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2014-00057
MDR Report Key3752990
Report Source06
Date Received2014-02-05
Date of Report2014-01-14
Date of Event2014-01-06
Date Mfgr Received2014-01-14
Device Manufacturer Date2013-06-01
Date Added to Maude2014-05-12
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 ContactMARGIE BURTON,CLINICAL SPLIST
Manufacturer StreetPO BOX 12600
Manufacturer CityDURHAM NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334965
Manufacturer G1TELEFLEX
Manufacturer StreetAVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO, TAMAULIPAS 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON ONE WAY VALVE, FEMALE TO MALE
Generic NameONE-WAY VALVE
Product CodeCBP
Date Received2014-02-05
Catalog Number1665
Lot Number02F1300863
OperatorOTHER
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressNUEVO LAREDO, TAMAULIPAS MX


Patients

Patient NumberTreatmentOutcomeDate
10 2014-02-05

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