PORTEX RSP TRACHEAL TUBE HOLDERS H4051

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 2012-07-13 for PORTEX RSP TRACHEAL TUBE HOLDERS H4051 manufactured by Smiths Medical International, Ltd..

Event Text Entries

[2844700] User facility reported that the lock mechanism on the endotracheal tube was too tight to allow passage of a suction catheter. As a result it was necessary to release the locking mechanism to allow passage of the suction catheter. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5


[10045831] Add'l mfr narrative: customer has not yet returned the device to the mfr for device eval. When and if the device becomes available and is returned and evaluated the mfr will file a follow-up report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2012-00302
MDR Report Key2666706
Report Source06
Date Received2012-07-13
Date of Report2012-07-10
Date of Event2012-06-12
Date Facility Aware2012-06-12
Report Date2012-07-10
Date Reported to FDA2012-07-10
Date Mfgr Received2012-06-13
Device Manufacturer Date2011-08-01
Date Added to Maude2012-07-26
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 StreetBOUNDRY 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 Received2012-07-13
Model NumberNA
Catalog NumberH4051
Lot Number2077179
ID NumberNA
Device Expiration Date2014-08-01
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 2012-07-13

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