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

Catalog Number 829155

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

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

Event Date 12/29/2022

Event Type  malfunction  

Manufacturer Narrative

Retained lot number 56712a was inspected for the suction, plunger and needle stiffness and no malfunction was found during testing.

Event Description

End user reports that the insulin syringe cannula is bending when inserting into the skin.The end user also reported that the syringe plunger is easy to remove, more often so than in the past.

Manufacturer Narrative

Retained lot number 56712a was inspected for the suction, plunger and needle stiffness and no malfunction was found during testing.Cmo tested affected device on 2-22-2023, no malfunction found during returned product testing.

Event Description

End user reports that the insulin syringe cannula is bending when inserting into the skin.The end user also reported that the syringe plunger is easy to remove, more often so than in the past.

• 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: 16185827
• MDR Text Key: 308349537
• Report Number: 3005798905-2023-03092
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

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: 829155
• Device Lot Number: 56712A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 12/29/2022
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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