PORTEX RSP TRACHEAL TUBE HOLDERS H4052

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-23 for PORTEX RSP TRACHEAL TUBE HOLDERS H4052 manufactured by Smiths Medical International Ltd.

Event Text Entries

[2929012] User facility reported that the tube holder is causing the tube to split. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5


[10015286] Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2012-00402
MDR Report Key2725552
Report Source06
Date Received2012-08-23
Date of Report2012-08-20
Report Date2012-08-20
Date Reported to FDA2012-08-20
Date Mfgr Received2012-07-30
Device Manufacturer Date2011-09-01
Date Added to Maude2012-09-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPETE HIRTE
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6516287384
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD.
Manufacturer StreetBOUNDARY ROAD
Manufacturer CityHYTHE, KENT CT216JL
Manufacturer CountryUK
Manufacturer Postal CodeCT21 6JL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX RSP TRACHEAL TUBE HOLDERS
Generic NameJAY - BREATHING TUBE SUPPORT
Product CodeJAY
Date Received2012-08-23
Model NumberNA
Catalog NumberH4052
Lot Number2116100
ID NumberNA
Device Expiration Date2014-09-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age10 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL INTERNATIONAL LTD
Manufacturer AddressHYTHE, KENT


Patients

Patient NumberTreatmentOutcomeDate
10 2012-08-23

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