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Adverse Event Report

BECTON DICKINSON DIVISION BD SYRINGE 1ML TUBERCULIN SYRINGE   back to search results
Catalog Number 309602
Event Date 08/15/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

Bd 1ml slip-tip insulin syringes are clearly labeled as "insulin syringe" while 1ml slip-tip tuberculin syringes are labeled as "tuberculin" on unit package. In addition the graphics on insulin syringe packages are printed in orange and black while the tuberculin syringe graphics are blue. The markings on the syringes themselves also differ significantly with the insulin syringe clearly labeled with the legend "use u-100 insulin only" and a scale going from 1-100 units in 10 unit increments with the word "units" appearing at the base of the units scale. The tuberculin syringe does not contain the insulin syringe legend and has a single ml scale marked in 0. 1 ml increments and is clearly labeled as "ml".

 
Event Description

A new graduate rn in orientation mistook the tb syringe, mfg by becton dickinson which is a 1ml syringe for an insulin syringe and drew up 90 units of insulin rather than nine and administered it to the pt. The pt was made aware of the error. The issue is really surrounding the ability to mix-up the two syringes. The distinction is not clear enough on the syringes themselves. The pt had a severe hypoglycemic reaction and was transferred to the intensive care unit, stabilized adn subsequently transferred back out to the floor.

 
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Brand NameBD SYRINGE
Type of Device1ML TUBERCULIN SYRINGE
Baseline Brand NameBD (TM) SYRINGE
Baseline Generic Name1ML TUBERCULIN SYRINGE
Baseline Catalogue Number309602
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BECTON DICKINSON DIVISION
route 7 & grace way
canaan CT 06018
Manufacturer (Section D)
BECTON DICKINSON DIVISION
route 7 & grace way
canaan CT 06018
Manufacturer Contact
michael pasino
1 becton drive
franklin lakes , NJ 07417
(201) 847 -4269
Device Event Key427874
MDR Report Key438951
Event Key415420
Report Number1213809-2003-00001
Device Sequence Number1
Product CodeFMF
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/20/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number309602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/14/2002
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 Initial

Database last updated on January 30, 2009

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