HUDSON SMOOTH-FLO CORR-A-TUBE,6' 1418

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2018-12-10 for HUDSON SMOOTH-FLO CORR-A-TUBE,6' 1418 manufactured by Teleflex Medical.

Event Text Entries

[129914929] (b)(4). The device involved has not been received for evaluation by the manufacturer at the time of this report. The device history record (dhr) of batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. Dhr shows that the product was assembled and inspected according to our specifications. Customer complaint cannot be confirmed based only on the information provided. To perform a proper investigation and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved in this complaint. If the sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10


[129914930] Customer complaint alleges that during functional testing prior to patient use there was a leak detected in the device. No patient involvement was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004365956-2018-00351
MDR Report Key8147075
Report SourceDISTRIBUTOR,FOREIGN,USER FACI
Date Received2018-12-10
Date of Report2018-11-26
Date of Event2018-11-17
Date Mfgr Received2019-01-04
Device Manufacturer Date2018-03-06
Date Added to Maude2018-12-10
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 StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON SMOOTH-FLO CORR-A-TUBE,6'
Generic NameSET, TUBING AND SUPPORT, VENTI
Product CodeBZO
Date Received2018-12-10
Returned To Mfg2018-12-05
Catalog Number1418
Lot Number74C1800972
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-10

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