HUDSON ET TUBE, SHER-I-BRONCH, LS, 39 FR 5-16039

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 2020-03-23 for HUDSON ET TUBE, SHER-I-BRONCH, LS, 39 FR 5-16039 manufactured by Teleflex Medical.

Event Text Entries

[184622226] (b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. Part number reported is not being manufactured currently, however, another part number from the same family was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 80 samples were taken from the current production; the samples were visually inspected and the issue reported was not observed in the current manufacturing process. Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature. If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10


[184622227] Customer reported the connector was found "cracked upon hooking up to patient". The patient was reported to be "fine" and a new device was used.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003898360-2020-00308
MDR Report Key9866774
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-23
Date of Report2020-03-09
Date of Event2020-03-03
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-23
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 ContactVICTORIA SANDLIN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
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, 39 FR
Generic NameTUBE, TRACHEAL/BRONCHIAL, DIFF
Product CodeCBI
Date Received2020-03-23
Catalog Number5-16039
Lot Number73H1900380
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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