MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASY TOUCH; INSULIN PEN NEEDLE

Catalog Number 831041

Device Problems Partial Blockage (1065); No Device Output (1435)

Patient Problem Missing Value Reason (3192)

Event Date 04/27/2018

Event Type  malfunction  

Event Description

Pen needles have blockage.Insulin will not come through the needles.

• Brand Name: EASY TOUCH
• Type of Device: INSULIN PEN NEEDLE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnati, OH 45240
• MDR Report Key: 7551658
• MDR Text Key: 109567674
• Report Number: 3005798905-2018-00555
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Pharmacist
• Device Expiration Date: 04/20/2022
• Device Catalogue Number: 831041
• Device Lot Number: 458302P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1