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

Catalog Number 831041

Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

Event Type  malfunction  

Event Description

Insulin will not come through pen needles.

Event Description

Insulin will not come through pen needles.

• Brand Name: EASYTOUCH
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 8695 seward rd.; fairfield OH 45011
• MDR Report Key: 9242377
• MDR Text Key: 163955734
• Report Number: 3005798905-2019-02857
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 831041
• Device Lot Number: 473704P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1