MAUDE Adverse Event Report: HTL-STREFA BD PEN NEEDLE

Device Problems Bent (1059); Insufficient Flow or Under Infusion (2182)

Patient Problem Underdose (2542)

Event Date 10/24/2017

Event Type  Injury  

Event Description

New droplet brand of pen needles did not allow for appropriate insulin flow and bent upon administration.Switched to previous brand of bd pen needles, insulin administration returned to normal.Symptoms: unable to get full dose of insulin with new needle; suspect drug, dosing: as directed with insulin.Dates of use: (b)(6) 2017 through na.

• Brand Name: BD PEN NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): HTL-STREFA
• MDR Report Key: 7285541
• MDR Text Key: 100672841
• Report Number: MW5075369
• Device Sequence Number: 0
• Product Code: FMI
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• 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: 63 YR