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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON & CO. BD INSULIN SYRINGES SYRINGE, PISTON

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BECTON DICKINSON & CO. BD INSULIN SYRINGES SYRINGE, PISTON Back to Search Results
Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
Hello, i want to bring this to your attention. It's been 5 years that my son 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. What do you think i should? it affected my son glucose for 5 years. The bd company send me an email: investigation results: samples were received and an investigation was performed. This is the 1st complaint for the reported lot number. A review of the manufacturing records was performed and no non- conformance's were raised in association with this type of event for this lot. Bd was not able to duplicate or confirm the indicated issue hence the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. Based on the above, no additional investigation and no corrective/ preventative action (capa) is required at this time. Your feedback and continued support is important to bd so that we may continue to provide you with the highest quality products. This will conclude and close the investigation, should you have further questions or concerns please feel free to contact me for assistance, "bd was not able to duplicate or confirm the indicated issue hence the root cause is undetermined. " where is the answer about the difference in the amount of insulin that goes into one syringe and another? where they answer about the fact that in one syringe enters 1 unit and in another enters 1. 5 unit? they did not answer my question. They only informed me: that there were no complaints about that lot, and that was not my complaint. Please help me. The difference exist and is very dangerous for our kids.
 
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Brand NameBD INSULIN SYRINGES
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON & CO.
MDR Report Key9581327
MDR Text Key174894561
Report NumberMW5092191
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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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