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

Model Number 08290-3249-11

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Bd insulin syringes fail to draw more than 0.025 ml of any fluid when used appropriately.Failure repeats in multiple lots and has been noted by multiple providers and patients, as well.

• Brand Name: BD INSULIN SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD ; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 7369249
• MDR Text Key: 103554957
• Report Number: MW5076084
• Device Sequence Number: 2
• 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: Nurse
• Type of Report: Initial
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08290-3249-11
• Device Lot Number: NUMEROUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1