BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL 170605-000160

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-18 for BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL 170605-000160 manufactured by Teleflex Medical Sdn. Bhd..

Event Text Entries

[186333506] (b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[186333507] The report states: we faced 3 issues with balloon deflation with catalog #171305, according to sales representative the size was ch 16. The consequences for the 3 patients were that a new catheter was inserted. The catheters were used for drainage. There is no device to be sent back for investigation. The customer stated the balloons were not fully deflated at removal, clarification about that fact was asked to the customer and the customer was not able to provide any further explanation about that fact. The customer was only able to report issue with balloons deflation (3 attempts made (b)(6) 2020). Clinical consequences: the balloons had to be re-inflated. And the catheters had to be replaced more often that it should be.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2020-00086
MDR Report Key9847837
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-18
Date of Report2020-02-26
Date of Event2020-02-01
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-18
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 ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
Manufacturer G1TELEFLEX MEDICAL SDN. BHD.
Manufacturer StreetLOT NO : PT2577 JALEN PERUSAHAAN 4 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 NameBRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
Product CodeEZL
Date Received2020-03-18
Catalog Number170605-000160
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL SDN. BHD.
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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