HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/DUAL W 780-15

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 2015-02-26 for HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/DUAL W 780-15 manufactured by Teleflex Medical.

Event Text Entries

[5471261] The customer alleges that the circuit did not pass the leak test. No pt injury.
Patient Sequence No: 1, Text Type: D, B5


[13073316] (b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history record of batch number 74l1402115 that belong to catalog number 780-15 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. No non conformance reports were originated for the lot in question that can be associated to the complaint reported. The dhr shows that the product was assembled and inspected according to our specifications. No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported. Customer complaint cannot be confirmed based only on the info provided, to perform an investigation and determine the source of defect reported, it is necessary to evaluate the sample involved on this complaint. An attempt to duplicate the failure mode was made but at the time there was no inventory of the involved product code available at the facility and it was not being mfg at the time. If device sample becomes available at a later date, this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2015-00074
MDR Report Key4563715
Report Source05,06,07
Date Received2015-02-26
Date of Report2015-02-02
Date of Event2015-01-29
Date Mfgr Received2015-02-02
Device Manufacturer Date2014-11-01
Date Added to Maude2015-04-01
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, NEONATAL, DUAL HTD LIMB W/DUAL W
Generic NameBREATHING CIRCUIT
Product CodeCAG
Date Received2015-02-26
Catalog Number780-15
Lot Number74L1402115
OperatorHEALTH PROFESSIONAL
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 2015-02-26

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