MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET PEN NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Device Problem Obstruction of Flow (2423)

Patient Problem Underdose (2542)

Event Date 02/08/2019

Event Type  Injury  

Event Description

Patient reports major difficulty injecting insulins using droplet brand pen needles.Main complaint is that the pen needles will plug up and he is only able to administer 20 units of insulin, then flow will stop, so he has to remove needle, replace it, and inject the other 20 units of insulin for his full dose.This is likely leading to under and overdosing on all occasions.Symptoms: inability to correctly administer insulin in the correct amounts.

• Brand Name: DROPLET PEN NEEDLE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): HTL-STREFA S.A.
• MDR Report Key: 8358974
• MDR Text Key: 137187467
• Report Number: MW5084171
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR