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Adverse Event Report

BECTON DICKINSON & COMPANY DURASAFE - BECTON DICKINSON EPIDURAL CATHETER TRAY/17G EPIDURAL NEEDLE   back to search results
Model Number DURASAFE TRAY
Event Date 03/07/1997
Event Description

Pt is sitting position, multiple attempts to place epidural, using plastic syringe provided. Initial attempts by resident hit bone, after each needle was withdrawn and repositioned. Also, some attempts were make to "walk off" the bone. Over several occasions it appeared there was loss of resistance to air (lorta) at very shallow depths (3 cm), but on subsequent attempts lorta appeared more appropriate. Attending took over and made several attempts with similar results, using above plastic syringe. Closer visual inspection revealed discolorations of plastic hub, i. E. Clear plastic had become opaque in several spots. Needle withdrawn and connected to a 3-cc fluid filled syringe. Tip of needle occluded and syringe injected. Fluid observed exiting through cracks in hub. New needle obtained. Epidural placed without further difficulty. At no time was a metal luer-locked syringe used, only the plastic non-luer provided in kit. Never any evidence of wet tap.

 
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Brand NameDURASAFE - BECTON DICKINSON
Type of DeviceEPIDURAL CATHETER TRAY/17G EPIDURAL NEEDLE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BECTON DICKINSON & COMPANY
1 becton drive
franklin lakes NJ 07417 1884
Manufacturer (Section D)
BECTON DICKINSON & COMPANY
1 becton drive
franklin lakes NJ 07417 1884
Device Event Key104640
MDR Report Key106443
Event Key100058
Report Number106443
Device Sequence Number1
Product CodeCAZ
Report Source User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 03/26/1997,03/12/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberDURASAFE TRAY
Device Catalogue Number407713
Device LOT Number7A019
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/10/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/12/1997
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer03/26/1997
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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