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

Catalog Number 829155

Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Material Integrity Problem (2978); Material Too Soft/Flexible (4007)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

Initial trend analysis for lot 60972a was conducted, no malfunctions were found.This is the only complaint for lot 60972a.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports that while using syringes with lot 60972a exp date 06/26/2028 is dull.User states the at times the rubber gasket will be when enough force is applied while injecting insulin.

Manufacturer Narrative

Cmo inspected retained lot 60972a, no abnormalities were found during testing.

Event Description

End user reports that while using syringes with lot 60972a exp date 06/26/2028 is dull.User states the at times the rubber gasket will be when enough force is applied while injecting insulin.

• Brand Name: EASYTOUCH
• Type of Device: SYRINGES
• 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: 18619376
• MDR Text Key: 334669309
• Report Number: 3005798905-2024-03161
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 60972A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1