MAUDE Adverse Event Report: FEEL TECH BIO CO., LTD. EASYTOUCH; INSULIN SYRINGE

Catalog Number 829155

Device Problems Mechanical Problem (1384); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

End user reports discrepancies between the different facilities that manufacture the easytouch syringes.The end user reports that syringe 829155, lot 59934a and lot 60705a do not have a trademark symbol on the barrel of the syringe, the needle is flimsy and the plunger is easily pulled out of the barrel.

Manufacturer Narrative

Initial trend analysis for lot 59934a was conducted, no malfunctions were found.This is the only complaint for lot 59934a.Further investigation will be conducted to determine the root cause of complaint.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): FEEL TECH BIO CO., LTD.; 1079-20, charyeongggogae-ro; gwangdeok-myeon, chungcheongnamdo 31223 ; KS 31223
• Manufacturer (Section G): FEEL TECH BIO CO., LTD.; 1079-20, charyeongggogae-ro; gwangdeok-myeon, chungcheongnamdo 31223 ; KS 31223
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 18069942
• MDR Text Key: 328144189
• Report Number: 3005798905-2023-03145
• 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
• Report Date: 11/03/2023

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 Catalogue Number: 829155
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/03/2023
• 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