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 2012-12-26 for PORTEX RSP TRACHEAL TUBE HOLDERS H4051 manufactured by Smiths Medical International Ltd..

Event Text Entries

[15513114] 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


[15753005] 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 f/u report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2012-00621
MDR Report Key2945193
Report Source06
Date Received2012-12-26
Date of Report2012-12-20
Report Date2012-12-20
Date Reported to FDA2012-12-20
Date Mfgr Received2012-11-21
Date Added to Maude2013-02-21
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 RD.
Manufacturer CityHYTHE, KENT
Manufacturer CountryUK
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 Received2012-12-26
Model NumberNA
Catalog NumberH4051
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL INTERNATIONAL LTD.
Manufacturer AddressHYTHE, KENT


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-26

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