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

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).

• Brand Name: BD INSULIN SYRINGES
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 9340931
• MDR Text Key: 167168230
• Report Number: MW5091141
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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