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

Catalog Number 831165

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

Initial trend analysis for lot 56533 was conducted, no malfunctions were found.This is the only complaint for lot 56533.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports that when injecting into the abdomen with the insulin medication, the insulin syringe needle is bending.

Manufacturer Narrative

No device was returned for testing.Retained lot number 56533 was investigated and met all requirements for iso9626 standards.The testing shows no indication of abnormalities or malfunction at time of production.

Event Description

End user reports that when injecting into the abdomen with the insulin medication, the insulin syringe needle is bending.

• Brand Name: EASYTOUCH
• Type of Device: 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: 15825766
• MDR Text Key: 307681491
• Report Number: 3005798905-2022-03084
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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: 56533
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1