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

Catalog Number 831061

Device Problems Failure to Deliver (2338); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

End user reports pen needle is bending during injection into skin from lot 583317p.End user also reports that the insulin did not inject into the skin but found on the floor.

Manufacturer Narrative

Initial trend analysis for lot 583317p was conducted, no malfunctions were found.This is the only complaint for lot 583317p.Further investigation will be conducted to determine the root cause of complaint.

Manufacturer Narrative

Retained lot 583317p inspected for needle sharpness, no abnormalities found during manufacturing process.

Event Description

End user reports pen needle is bending during injection into skin from lot 583317p.End user also reports that the insulin did not inject into the skin but found on the floor.

• Brand Name: EASYTOUCH
• Type of Device: PEN NEEDLE
• 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: 17885965
• MDR Text Key: 325085829
• Report Number: 3005798905-2023-03140
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112789
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 831061
• Device Lot Number: 583317P
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2023
• 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