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

Catalog Number 831365

Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

End user reports that the syringes 831365 lot 59363c are almost too dull to penetrate the novalog insulin vial prior to use.

Manufacturer Narrative

Initial trend analysis for lot 59363c was conducted, no malfunctions were found.This is the only complaint for lot 59363c.Further investigation will be conducted to determine the root cause of complaint.

Manufacturer Narrative

Cmo inspected retained lot 59363c for needle sharpness, no abnormalities were found during testing.

Event Description

End user reports that the syringes 831365 lot 59363c are almost too dull to penetrate the novalog insulin vial prior to use.

• 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: 17471905
• MDR Text Key: 320780747
• Report Number: 3005798905-2023-03131
• 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: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 831365
• Device Lot Number: 59363C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 09/27/2023
• 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