MAUDE Adverse Event Report: PENNEEDLE UF MINI 31GX5MM; NEEDLE, HYPODERMIC, SINGLE LUEMN

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Blood Loss (2597)

Event Date 02/13/2019

Event Type  Injury  

Event Description

The patient reported having received wrong pen needle size with last forteo refill.She received 8mm size, instead of 5mm.She stated that the 8mm size was making her bleed.

• Brand Name: PENNEEDLE UF MINI 31GX5MM
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUEMN
• MDR Report Key: 8546813
• MDR Text Key: 143132582
• Report Number: MW5086149
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• 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: 89 YR