HUDSON SMOOTH-FLOW FLEX 22552

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-22 for HUDSON SMOOTH-FLOW FLEX 22552 manufactured by Teleflex Medical.

Event Text Entries

[151782796] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[151782797] Customer reported that "catheter mount showed a tear at the beginning of the connector when packaging was opened (area between connector and tube). " the alleged issue was detected prior to use and there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2019-00184
MDR Report Key8813370
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-22
Date of Report2019-07-02
Date of Event2019-07-02
Date Mfgr Received2019-08-20
Device Manufacturer Date2018-04-06
Date Added to Maude2019-07-22
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 StreetPO BOX 28, KAMUNTING INDUSTRIAL ESTATE
Manufacturer CityPERAK, WEST MALAYSIA 34600
Manufacturer CountryMY
Manufacturer Postal Code34600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON SMOOTH-FLOW FLEX
Generic NameSET, TUBING SUPPORT W/HARNESS
Product CodeBZO
Date Received2019-07-22
Catalog Number22552
Lot Number201814
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-22

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