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

Catalog Number 831165

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

Patient Problem Pain (1994)

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

Production records investigated for lot number 64843a.The testing showed no indication of abnormalities or malfunction at time of production.

Event Description

End user reports that a box of insulin syringes lot 64843a exp 7/6/2028 were extremely dull and painful.User reports the needle wasn't as sharp or smooth when injecting into the person as if there was no lubrication on the needle.

Event Description

End user reports that a box of insulin syringes lot 64843a exp 7/6/2028 were extremely dull and painful.User reports the needle wasn't as sharp or smooth when injecting into the person as if there was no lubrication on the needle.

Manufacturer Narrative

Cmo inspected retained lot 64843a, no abnormalities were found during testing.

• 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: 18520928
• MDR Text Key: 333223737
• Report Number: 3005798905-2024-03158
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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: 64843A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2024
• 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