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

Catalog Number 832041

Device Problems Break (1069); Material Fragmentation (1261); Dull, Blunt (2407)

Patient Problems Inflammation (1932); Needle Stick/Puncture (2462); Skin Inflammation/ Irritation (4545)

Event Date 12/30/2021

Event Type  malfunction  

Manufacturer Narrative

During follow-up call to end user, end user reports that the doctor determined there were no fragments of the cannula remaining inside the skin and the sore was caused by the end user whilst attempting to locate the fragments of the cannula with tweezers.No device was returned for testing.The root cause of the complaint is traced to end user reusing the pen needles multiple times and the pen needles being expired 06/2019.

Event Description

On the (b)(6) 2021 an end user reports that a month prior ((b)(6) 2021) to reporting the complaint, while using an expired box of pen needles that were purchased in the year 2014 she believed that a part of the cannula broke off into skin.The user inspected herself using tweezers and could not identify any particles of the cannula left behind in her skin.The end user reports an open sore in their skin at source of insertion and has not seen her doctor as of yet on the date of (b)(6) 2021 regarding the open sore.

• Brand Name: EASYTOUCH
• Type of Device: PEN NEEDLE
• 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: 13172082
• MDR Text Key: 283277504
• Report Number: 3005798905-2022-03029
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 832041
• Device Lot Number: P14240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/05/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other