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

Catalog Number 832041

Device Problems Improper Flow or Infusion (2954); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

Event Type  malfunction  

Event Description

Insulin is not coming out of pen needle.Pen needle appears to be clogged.

Event Description

Insulin is not coming out of pen needle.Pen needle appears to be clogged.

• Brand Name: EASYTOUCH
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 8695 seward rd.; fairfield, oh OH 45011
• MDR Report Key: 9665349
• MDR Text Key: 178018935
• Report Number: 3005798905-2020-02905
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: K112789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 832041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other