PORTEX NEONATAL PEDIATGRIC TRACHEAL TUBE HOLDER H4051

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-08-06 for PORTEX NEONATAL PEDIATGRIC TRACHEAL TUBE HOLDER H4051 manufactured by Smiths Medical Int'l Ltd.

Event Text Entries

[19085218] User facility reported difficulty passing the suction catheter through the tracheal tube holder. No permanent adverse effects to pt reported.
Patient Sequence No: 1, Text Type: D, B5


[19129616] Customer has not yet returned the device to the manufacturer for device eval. When and if the device becomes available and is returned and evaluated, the manufacturer will file a f/u report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2014-00560
MDR Report Key4048021
Report Source05,06
Date Received2014-08-06
Date of Report2014-08-05
Report Date2014-08-05
Date Reported to FDA2014-08-05
Date Mfgr Received2013-05-09
Date Added to Maude2014-09-08
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 INT'L LTD
Manufacturer StreetBOUNDARY RD
Manufacturer CityHYTHE, KENT CT216JL
Manufacturer CountryUK
Manufacturer Postal CodeCT21 6JL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX NEONATAL PEDIATGRIC TRACHEAL TUBE HOLDER
Generic NameJAY-SUPPORT, BREATHING TUBE
Product CodeJAY
Date Received2014-08-06
Model NumberNA
Catalog NumberH4051
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL INT'L LTD
Manufacturer AddressHYTHE, KENT


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-06

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