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Adverse Event Report

C.R. BARD, INC. BARD BARDIC CUTDOWN CATH   back to search results
Catalog Number 1612
Patient Outcome  Required Intervention;
Event Description

Cutdown catheter inserted in lower leg. Two and a half hrs later intravenous site was bleeding. Nurse found that the catheter had broken away from the hub. Broken catheter was replaced. There was no apparent injury to the pt.

 
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Brand NameBARD
Type of DeviceBARDIC CUTDOWN CATH
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
C.R. BARD, INC.
5425 w amelia earhart dr.
salt lake city UT 84116
Device Event Key234070
MDR Report Key241596
Event Key226678
Report NumberMW1017204
Device Sequence Number1
Product CodeFOZ
Report Source Voluntary
Report Date 09/15/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1612
Device LOT Number0361090
OTHER Device ID Number22 GAUGE
Was Device Available For Evaluation? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on December 31, 2008

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