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Adverse Event Report

3600-C.R. BARD ACCESS SYSTEMS PRODUCTS NIAGRA PC D/L 20 CM KIT HEMODIALYSIS NON-IMPLANTED   back to search results
Model Number 5594200
Device Problems Crack(s); Repair
Event Type  Malfunction   Patient Outcome  Other;
Event Description

The hard plastic part of the lumen is cracking. The whole catheter has been replaced in the past. They are removing one tomorrow, but are trying to get a repair kit so they can repair instead of pulling the whole catheter.

 
Manufacturer Narrative

No product was sent back for evaluation, result were inconclusive. Complaint history review not possible, as no lot number was provided.

 
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Brand NameNIAGRA PC D/L 20 CM KIT
Type of DeviceHEMODIALYSIS NON-IMPLANTED
Baseline Brand NameNIAGARA ACUTE PRE CURVED DIALYSIS KIT, 20CM
Baseline Generic NameHEMODIALYSIS, NON-IMPLANTED
Baseline Catalogue Number5594200
Baseline Model Number5594200
Baseline Device FamilyNIAGARA ACUTE DIALYSIS CATHETER
Baseline Device 510(K) NumberK965178
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed08/19/1997
Manufacturer (Section F)
3600-C.R. BARD ACCESS SYSTEMS PRODUCTS
5425 west amelia earhart dr.
salt lake city UT 84166
Manufacturer (Section D)
3600-C.R. BARD ACCESS SYSTEMS PRODUCTS
5425 west amelia earhart dr.
salt lake city UT 84166
Manufacturer Contact
bryan ball, mgr.
5425 west amelia earhart dr.
salt lake city , UT 84116
(801) 595 -0700
Device Event Key387596
MDR Report Key398552
Event Key376604
Report Number1720496-2002-00112
Device Sequence Number1
Product CodeMPB
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 05/09/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number5594200
Device Catalogue Number5594200
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageno info
Event Location Hospital
Date Report TO Manufacturer05/09/2002
Date Manufacturer Received05/09/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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