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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON U100 SYRINGE SYRINGE, PISTON

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BECTON DICKINSON U100 SYRINGE SYRINGE, PISTON Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Hypoglycemia (1912)
Event Description
A nurse at a non-24 hour hospital in the "xxxxxxxxx" regional health system used a u100 syringe to pull up and administer a dose of us00 insulin on accident. The patient became hypoglycemic requiring action to correct. (b)(6). Submission id: (b)(4).
 
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Brand NameU100 SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key12892935
MDR Text Key281678746
Report NumberMW5105651
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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