MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; INSULIN SYRINGE

Catalog Number 831565

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Trend analysis was conducted to determine whether or not there were historical complaints or recent trends that show issues where packaging dye was rubbing off.There were no identifiable trends when investigated for lots 51206 or 51146.Retained lot testing was next conducted to try and trace the issue, however, none of the retained lots experience issues where the dye would rub off.And experiment was carried out to determine what might cause the packaging to fade or rub off.The end-user reported they stored their syringes in the kitchen.Packaging was tested in an environment of higher temperature, oil, and water to see if packaging would discolor or rub off.The high temperature, oil, and water did not cause any fading, however, alcohol did cause the packaging to fade.The storage location of the device is believed to be the cause the dye rubbing/fading off.

Event Description

End-user reported that their dye is rubbing off of the product packaging for their insulin syringes.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 11597389
• MDR Text Key: 246472631
• Report Number: 3005798905-2021-02994
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 831565
• Device Lot Number: 51206, 51146
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1