MAUDE Adverse Event Report: BECTON DICKINSON YALE NEEDLES MIS 30G X 1/2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Overdose (1988); Underdose (2542); Missed Dose (2561)

Event Date 06/06/2018

Event Type  No Answer Provided  

Event Description

Pt stated she was running out of meds early.Admitted she wasn't measuring out dose properly (she wasn't wearing her glasses).Informed her on how to dose and importance of correctly measuring out dose.Dates of use: from (b)(6) 2018 to (b)(6) 2018, subcutaneous.

• Brand Name: YALE NEEDLES MIS 30G X 1/2
• Type of Device: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 7591205
• MDR Text Key: 110865012
• Report Number: MW5077783
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 0829305106
• UDI-Public: 0829305106
• Combination Product (y/n): N
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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 Age: 48 YR