PORTEX NEONATAL/PEDIATRIC 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 2013-11-22 for PORTEX NEONATAL/PEDIATRIC TRACHEAL TUBE HOLDER H4051 manufactured by Smiths Medical International Ltd..

Event Text Entries

[4010787] User facility reported difficulty passing the suction catheter through the tracheal tube holder. Replacement of the tracheal tube was required. No permanent adverse effects to pt reported.
Patient Sequence No: 1, Text Type: D, B5


[11297881] 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 Number2183502-2013-00751
MDR Report Key3496649
Report Source05,06
Date Received2013-11-22
Date of Report2013-11-21
Date of Event2013-10-23
Date Facility Aware2013-10-23
Report Date2013-11-21
Date Reported to FDA2013-11-21
Date Mfgr Received2013-10-24
Device Manufacturer Date2013-04-01
Date Added to Maude2013-12-04
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 ROAD
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 NEONATAL/PEDIATRIC TRACHEAL TUBE HOLDER
Generic NameJAY - SUPPORT, BREATHING TUBE
Product CodeJAY
Date Received2013-11-22
Model NumberNA
Catalog NumberH4051
Lot Number2453473
ID NumberNA
Device Expiration Date2016-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age7 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL INTERNATIONAL LTD.
Manufacturer AddressHYTHE, KENT UK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-11-22

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