HUDSON SINGLE HEATED DUAL LIMB W DRAIN 880-34KIT

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 2015-01-06 for HUDSON SINGLE HEATED DUAL LIMB W DRAIN 880-34KIT manufactured by Teleflex Medical.

Event Text Entries

[5120226] The customer alleges that the circuit has a split in the seam. The tech noticed this alleged defect before installing on the ventilator. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[12744739] (b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2015-00015
MDR Report Key4398571
Report Source05,06,07
Date Received2015-01-06
Date of Report2014-12-10
Date of Event2014-12-09
Date Mfgr Received2014-12-10
Device Manufacturer Date2014-07-01
Date Added to Maude2015-01-21
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 SINGLE HEATED DUAL LIMB W DRAIN
Generic NameBREATHING CIRCUIT
Product CodeCAG
Date Received2015-01-06
Catalog Number880-34KIT
Lot Number74G1401890
OperatorOTHER
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 2015-01-06

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