MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. EASYTOUCH; SAFETY PEN NEEDLE

Catalog Number 829536

Device Problems Defective Device (2588); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Event Description

Safety pen needle shield cover would not retract in order to give an injection.Also appears that there is some insulin left in the pen needle.

• Brand Name: EASYTOUCH
• Type of Device: SAFETY PEN NEEDLE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 8695 seward rd.; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC.; 8695 seward rd.; fairfield OH 45011
• Manufacturer Contact: jennifer seiple ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 9242397
• MDR Text Key: 163957014
• Report Number: 3005798905-2019-02888
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 829536
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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