HUDSON PEDIATRIC BREATHING CIRCUIT, 30" 353801

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,08 report with the FDA on 2014-07-24 for HUDSON PEDIATRIC BREATHING CIRCUIT, 30" 353801 manufactured by Teleflex.

Event Text Entries

[4889127] The complaint is reported as: the end of the circuit cracked during use. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[12306815] The device history record of batch number (b)(4) was reviewed and there were no issues or discrepancies found that could relate to the reported complaint. No non-conformance reports were originated for the lot in question. The dhr shows that the product was assembled and inspected according to specifications. The sample was received, however, the investigation results were not complete at the time of this report. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2014-00278
MDR Report Key3994046
Report Source01,06,07,08
Date Received2014-07-24
Date of Report2014-07-10
Date of Event2014-06-28
Date Mfgr Received2014-07-10
Device Manufacturer Date2013-08-01
Date Added to Maude2014-08-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKATHARINE TARPLEY
Manufacturer StreetP.O. BOX 12600
Manufacturer CityRTP NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334854
Manufacturer StreetAVE. INDUSTRIAS NO.5954 PARQUE 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 PEDIATRIC BREATHING CIRCUIT, 30"
Generic NameANESTHESIA BREATHING CIRCUIT
Product CodeBSJ
Date Received2014-07-24
Returned To Mfg2014-07-17
Catalog Number353801
Lot Number02H1301128
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX
Manufacturer AddressNUEVO LAREDO MX


Patients

Patient NumberTreatmentOutcomeDate
10 2014-07-24

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