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 2015-02-25 for SINGLE HEATED DUAL LIMB W DRAIN 880-34KIT manufactured by Teleflex Medical.

Event Text Entries

[21565828] The customer alleges the circuit was observed to be cracked prior to use on patient. There was no patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5


[21813543] (b)(4). Device history record (dhr) review was performed on the reported lot# and there were no issues related to functional issues neither on the product or components during the manufacturing of the material. The reported complaint cannot be confirmed at this time because the defective sample is currently being investigated. The reported defect is a known issue and is currently being investigated by the manufacturer to determine the root cause of the reported failure. When additional information is provided a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2015-00066
MDR Report Key4552867
Report Source05,06,07
Date Received2015-02-25
Date of Report2015-02-02
Date of Event2015-01-29
Date Mfgr Received2015-02-02
Device Manufacturer Date2014-07-01
Date Added to Maude2015-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactWARRENDA PETERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9193613959
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPARQUE 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 NameSINGLE HEATED DUAL LIMB W DRAIN
Generic NameBREATHING CIRCUIT
Product CodeCAG
Date Received2015-02-25
Returned To Mfg2015-02-13
Catalog Number880-34KIT
Lot Number74G1401890
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-02-25

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