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Adverse Event Report

C.R. BARD, INC.(BASD) OPTI-FLOW CATHETER IMPLANTED BLOOD ACCESS DEVICE   back to search results
Model Number 5633690
Device Problems Fracture(s) of device/material; Implant, removal of
Event Date 04/01/2002
Event Type  Malfunction   Patient Outcome  Other; Required Intervention
Event Description

The catheter was removed and the cuff remained in the pt. Pt was operated under local anesthesia to remove the cuff.

 
Manufacturer Narrative

No product was returned for evaluation. Results were inconclusive. Complaint history review was not possible, as no lot number was provided.

 
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Brand NameOPTI-FLOW CATHETER
Type of DeviceIMPLANTED BLOOD ACCESS DEVICE
Baseline Brand NameOPTI-FLOW STRAIGHT DL 19 CM KIT
Baseline Generic NameIMPLANTED BLOOD ACCESS DEVICE
Baseline Catalogue Number5633690
Baseline Model Number5633690
Baseline Device FamilySOFTCELL CHRONIC D/L HEMODIALYSIS CATHETERS
Baseline Device 510(K) NumberK981994
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed09/14/2000
Manufacturer (Section F)
C.R. BARD, INC.(BASD)
5425 west amelia earhart dr.
salt lake city UT 84116
Manufacturer (Section D)
C.R. BARD, INC.(BASD)
5425 west amelia earhart dr.
salt lake city UT 84116
Manufacturer Contact
bryan ball, mgr.
5425 west amelia earhart dr.
salt lake city , UT 84116
(801) 595 -0700
Device Event Key381222
MDR Report Key392193
Event Key370456
Report Number1720496-2002-00081
Device Sequence Number1
Product CodeMSD
Report Source Manufacturer
Source Type Foreign,Other
Reporter Occupation Other
Type of Report Initial
Report Date 04/04/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number5633690
Device Catalogue Number5633690
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/01/2002
Device Ageno info
Event Location Hospital
Date Report TO Manufacturer04/04/2002
Date Manufacturer Received04/04/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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