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

Catalog Number 828155

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

Trend analysis and production records investigated for lot 56705a, no abnormalities found.The root cause of the complaint found to be due to intentional unintended use of device.

Event Description

A case manager from a syringe exchange program relayed the information that the syringe users are reporting skin irritation, burrs and plunger suction difficulties.Due to the syringes being used for unintended use as indicated by the reporter, the syringes are not malfunctioning.

Event Description

A case manager from a syringe exchange program relayed the information that the syringe users are reporting skin irritation, burrs and plunger suction difficulties.Due to the syringes being used for unintended use as indicated by the reporter, the syringes are not malfunctioning.

Manufacturer Narrative

Retained lot samples for syringe lot 56705a were tested for needle sharpness and plunger slip.No abnormalities were found during testing.

• 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: 17885967
• MDR Text Key: 325086279
• Report Number: 3005798905-2023-03141
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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: 828155
• Device Lot Number: 56705A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2023
• 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: Unknown
• Patient Sequence Number: 1