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

Catalog Number 831165

Device Problems Break (1069); Product Quality Problem (1506); Dull, Blunt (2407); Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

Initial trend analysis for lots 55052a and 65521a was conducted, no malfunctions were found.This is the only complaint for lots 55052a and 65521a.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reported to a direct customer that while using item 831165 lot 65521a cannula is burred, flimsy and on one account the cannula broke off.This user was sent replacements by the direct customer item 831165 lot 55052a, following up that the cannulas on this lot were also flimsy and burred.User reports that cannula breaking off at the tip as well as near the hub.

Manufacturer Narrative

Retained lot samples for syringe lot 65521a were tested for needle sharpness, no abnormalities were found during testing.

Event Description

End user reported to a direct customer that while using item (b)(4) lot 65521a cannula is burred, flimsy and on one account the cannula broke off.This user was sent replacements by the direct customer item (b)(4) lot 55052a, following up that the cannulas on this lot were also flimsy and burred.User reports that cannula breaking off at the tip as well as near the hub.

• 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: 18695313
• MDR Text Key: 335251927
• Report Number: 3005798905-2024-03164
• 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: Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 831165
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2024
• 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