BIOFLEX TESIO CATHETER BFR1035KD-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2006-04-24 for BIOFLEX TESIO CATHETER BFR1035KD-A manufactured by Medcomp.

Event Text Entries

[441041] "during the regular site care the nurse noticed the catheter had been cracked. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2518902-2006-00017
MDR Report Key705485
Report Source01,08
Date Received2006-04-24
Date of Report2006-04-21
Date of Event2006-03-09
Date Mfgr Received2006-03-27
Device Manufacturer Date2005-07-01
Date Added to Maude2006-05-01
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 Location0
Manufacturer ContactSUSAN SMITH, RN
Manufacturer Street1499 DELP DRIVE
Manufacturer CityHARLEYSVILLE PA 19438
Manufacturer CountryUS
Manufacturer Postal19438
Manufacturer Phone2152564201
Manufacturer G1MEDCOMP
Manufacturer Street1499 DELP DRIVE
Manufacturer CityHARLEYSVILLE PA 19438
Manufacturer CountryUS
Manufacturer Postal Code19438
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOFLEX TESIO CATHETER
Generic NameHEMODIALYSIS CATHETER
Product CodeLFG
Date Received2006-04-24
Returned To Mfg2006-04-03
Model NumberBFR1035KD-A
Catalog NumberBFR1035KD-A
Lot NumberMACD680
ID NumberNA
Device Expiration Date2010-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key694552
ManufacturerMEDCOMP
Manufacturer Address* HARLEYSVILLE PA * US
Baseline Brand Name10F BIOFLEX TESIO KIT
Baseline Generic NameHEMODIALYSIS CATHETER
Baseline Model NoNA
Baseline Catalog NoBFR1035KD-A
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-04-24

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