MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; SYRINGE

Catalog Number 829555

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

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

End user reports that one syringe from a box of 100 of syringes of item number 829555 lot number 57091b expiration date 12/02/2026 felt different while injecting into the skin.Upon the end user's own investigation with a magnifying glass, the end of the cannula was burred.

Manufacturer Narrative

Initial trend analysis for lot 57091b was conducted, no malfunctions were found.This is the only complaint for lot 57091b.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports that one syringe from a box of (b)(4) of syringes of item number 829555 lot number 57091b expiration date 12/02/2026 felt different while injecting into the skin.Upon the end user's own investigation with a magnifying glass, the end of the cannula was burred.

Manufacturer Narrative

No device was returned for testing.Retained lot number 57091b were investigated for needle sharpness test and visual inspection.All 50 retained lot samples passed investigation tests, no abnormalities found.

• Brand Name: EASYTOUCH
• Type of Device: SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 16396686
• MDR Text Key: 310152189
• Report Number: 3005798905-2023-03101
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 829555
• Device Lot Number: 57091B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2023
• 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