HUDSON ET TUBE, SHER-I-BRONCH, LS, 35 FR 5-16035

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-21 for HUDSON ET TUBE, SHER-I-BRONCH, LS, 35 FR 5-16035 manufactured by Teleflex Medical.

Event Text Entries

[169878935] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[169878936] Customer reported the connection broke during patient use (captured in 3003898360-2019-01238) and the physician proceeded to get another y connector from a new box. When the physician opened the new box, the connector was found broken in the box. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003898360-2019-01241
MDR Report Key9215730
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-10-21
Date of Report2019-09-30
Date of Event2019-08-09
Date Mfgr Received2019-10-22
Device Manufacturer Date2019-02-13
Date Added to Maude2019-10-21
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 ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetRANCHO EL DESCANSO
Manufacturer CityTECATE 21478
Manufacturer CountryMX
Manufacturer Postal Code21478
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON ET TUBE, SHER-I-BRONCH, LS, 35 FR
Generic NameTUBE, TRACHEAL/BRONCHIAL, DIFF
Product CodeCBI
Date Received2019-10-21
Catalog Number5-16035
Lot Number73B1900372
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-21

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