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

Catalog Number 827155

Device Problems Product Quality Problem (1506); Dull, Blunt (2407)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

Initial trend analysis for lot 63931a was conducted, no malfunctions were found.This is the only complaint for lot 63931a.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports that the plunger of syringe lot 63931a is falling out of the barrel easily, causing the user to lose insulin.User also reports that the cannula is "not comfortable".

Manufacturer Narrative

Cmo inspected retained lot 63931a no abnormalities were found during testing.

Event Description

End user reports that the plunger of syringe lot 63931a is falling out of the barrel easily, causing the user to lose insulin.User also reports that the cannula is "not comfortable".

• Brand Name: EASYTOUCH
• Type of Device: 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: 18926595
• MDR Text Key: 337948137
• Report Number: 3005798905-2024-03168
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 827155
• Device Lot Number: 63931A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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