MAUDE Adverse Event Report: BD BD SYRINGE INSULIN SAFETY GLIDE 1 ML; SYRINGE, PISTON

Model Number 594674

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2019

Event Type  malfunction  

Event Description

Turbidity / floaters seen in novolog insulin vial.Expected that this is due to the lubricant from the insulin syringes used.Fda safety report id# (b)(4).

• Brand Name: BD SYRINGE INSULIN SAFETY GLIDE 1 ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 9069927
• MDR Text Key: 158849996
• Report Number: MW5089794
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 594674
• Device Catalogue Number: 328446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1