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Adverse Event Report

BARD ENDOSCOPIC TECHNOLOGIES CR BARD GAUDERER GENIE PEG SYSTEM FEEDING   back to search results
Model Number 61 000394
Device Problem Component(s), detachment of
Event Date 02/07/2002
Event Type  Malfunction  
Event Description

Per contact, the md turned the tube to establish patency and tried to remove the peg via traction method. The dome broke off and is in the patient. The md is watching the dome at the moment. Device was implanted over one year ago. Facility is filing medwatch. Received call from contact 02/2002 - patient passed the dome.

 
Manufacturer Narrative

Per warning section of the instruction for use (ifu) ae1900134/03 for the gaud peg system, gastrotomy tubes which have been in place for long periods of time may have an increased potential for dome separation during a traction removal.

 
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Brand NameGAUDERER GENIE PEG SYSTEM
Type of DeviceFEEDING
Baseline Brand NameGAUDERER GENIE PEG SYSTEM
Baseline Generic NameFEEDING TUBE
Baseline Catalogue Number61 000394
Baseline Model Number61 000394
Baseline Device FamilyFEEDING
Baseline Device 510(K) NumberK915837
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date First Marketed12/14/1999
Manufacturer (Section F)
BARD ENDOSCOPIC TECHNOLOGIES CR BARD
129 concord rd., bldg. 3
billerica MA 01821
Manufacturer (Section D)
BARD ENDOSCOPIC TECHNOLOGIES CR BARD
129 concord rd., bldg. 3
billerica MA 01821
Manufacturer Contact
nancy cutino
129 concord road bldg #3
billerica , MA 01821
(978) 663 -8989
Device Event Key369579
MDR Report Key380532
Event Key359191
Report Number1223688-2002-00020
Device Sequence Number1
Product CodeKNT
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 03/04/2002,02/07/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/01/2004
Device MODEL Number61 000394
Device Catalogue Number61 000394
Device LOT Number43CKA029
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/15/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/07/2002
Device Age02 yr
Event Location Nursing Home
Date Manufacturer Received02/07/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2000
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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