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

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.

• Brand Name: BD INSULIN SYRINGES
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 9581327
• MDR Text Key: 174894561
• Report Number: MW5092191
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 23