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

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).

• Brand Name: U100 SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 12892935
• MDR Text Key: 281678746
• Report Number: MW5105651
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1