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

Catalog Number 831165

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/06/2020

Event Type  Injury  

Event Description

End-user was recapping insulin syrige and accidentally pushed the needle through the cap and into her finger.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN SYRINGE
• 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: kristin peters ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 9743050
• MDR Text Key: 191915341
• Report Number: 3005798905-2020-02912
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/06/2020

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: 831165
• Device Lot Number: 48225A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/23/2020
• 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
• Patient Outcome(s): Other