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Adverse Event Report

C.R. BARD, INC. BARD FEEDING TUBE   back to search results
Catalog Number 0036400
Device Problem Perforation
Event Date 07/11/1999
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Allegations have been made that the placement of a feeding tube tore/perforated the intestines and resulted in bleeding and surgical intervention on a pt. This info was provided by an attorney representing the hosp. A search of the complaint database showed this event had not been reported previously. No add'l info was provided concerning this event.

 
Manufacturer Narrative

This info was provided to the co law dept and will be handled by the co's law dept. There was no alleged failure of the device to perform its intended function. The nature of the event referred to the placement of the product. Placement of such devices is determined by the treating physician, pt differences and hosp protocol.

 
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Brand NameBARD FEEDING TUBE
Type of DeviceFEEDING TUBE
Baseline Brand NameBARD FEEDING TUBES
Baseline Generic NameFEEDING TUBES
Baseline Catalogue Number0036400
Baseline Device FamilyBARD FEEDING TUBE
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed02/15/1985
Manufacturer (Section F)
C.R. BARD, INC.
8195 industrial blvd.
covington GA 30014
Manufacturer (Section D)
C.R. BARD, INC.
8195 industrial blvd.
covington GA 30014
Manufacturer (Section G)
BARD VSD
industrial park
las piedras PR 00771 2001
Manufacturer Contact
vivian stephens, manager
8195 indust. blvd
convington , GA 30014
(770) 784 -6902
Device Event Key311163
MDR Report Key321626
Event Key302542
Report Number1018233-2001-00009
Device Sequence Number1
Product CodeKNT
Report Source Manufacturer
Source Type Other
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 02/20/2001,03/21/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0036400
Device LOT Number76FJ2505
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Age1 mo
Event Location Hospital
Date Manufacturer Received02/20/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/1999
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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