HUDSON STYLET,SOFT TIP,6 FR 5-15120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-01-10 for HUDSON STYLET,SOFT TIP,6 FR 5-15120 manufactured by Teleflex Medical.

Event Text Entries

[132776107] Qn# (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[132776108] Customer complaint alleges "a piece of plastic was found in the mouth of a (b)(6) new-born baby while he had a big cough. According to doctors, this piece of plastic is a part of the stylet of the intubation tube. (continued) it's 4-5 cm length (see pic 2). The doctor who performed the action reported an unsusual resistance whilst he removed the stylet. " customer submitted a photo for reference. The patient condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003898360-2019-00063
MDR Report Key8236972
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-01-10
Date of Report2018-12-20
Date of Event2018-12-15
Date Mfgr Received2019-02-06
Date Added to Maude2019-01-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 STYLET,SOFT TIP,6 FR
Generic NameSTYLET, TRACHEAL TUBE
Product CodeBSR
Date Received2019-01-10
Returned To Mfg2019-01-23
Catalog Number5-15120
Lot NumberUNKNOWN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-10

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