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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD INSULIN SYRINGES SYRINGE, PISTON

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BD BD INSULIN SYRINGES SYRINGE, PISTON Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2012
Event Type  malfunction  
Event Description
Hello, i want to bring this to your attention. It's been 5 years that my son has been using the bd syringes and each box had different measurements, such as the pictures there. In all cases the measurements were different. In one of the pictures it shows a syringe of 1 unit and the other one the same 1 unit shows 1. 5 units. I have been fighting with bd about this. It affected my son glucose for 5 years. He is (b)(6) y/o. Those errors can cause hypoglycemia and hyperglycemia which can lead to death causes. Fda safety report id# (b)(4).
 
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Brand NameBD INSULIN SYRINGES
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key9340931
MDR Text Key167168230
Report NumberMW5091141
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 11/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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