HUDSON CIRCUIT ACCESSORY, HTD WIRE, INSPIRATORY 780-19

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-03-20 for HUDSON CIRCUIT ACCESSORY, HTD WIRE, INSPIRATORY 780-19 manufactured by Teleflex Medical.

Event Text Entries

[5767098] The customer alleges that the circuit melted while on a pt. No report of pt injury or harm.
Patient Sequence No: 1, Text Type: D, B5


[13113990] (b)(4). A visual, functional and dimensional inspection of the prod involved in the complaint could not be conducted since the prod was not rec'd at out facility. A device history record review could not be conducted since the lot number was not provided. No corrective action can be established at this time since the device sample or a picture of it is not available for evaluation. Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause. An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility and it is not being mfg at the time. If the physical sample becomes available this complaint will be reopened.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2015-00104
MDR Report Key4627791
Report Source05,06,07
Date Received2015-03-20
Date of Report2015-02-26
Date of Event2015-02-26
Date Mfgr Received2015-02-26
Date Added to Maude2015-05-07
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 ContactMARGIE BURTON, RN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334965
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 CIRCUIT ACCESSORY, HTD WIRE, INSPIRATORY
Generic NameBREATHING CIRCUIT
Product CodeCAG
Date Received2015-03-20
Catalog Number780-19
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-20

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