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

Catalog Number 829555

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

Initial trend analysis for lot 55121 was conducted, no malfunctions were found.This is the only complaint for lot 55121.The syringes appear "wet" to the end user due to the lubrication used inside of the syringe.

Event Description

End user reports that insulin syringe item number 829555 from lot 55121 appear to be wet inside.

• Brand Name: EASYTOUCH
• Type of Device: SYRINGES
• 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: 15283381
• MDR Text Key: 305362784
• Report Number: 3005798905-2022-03072
• 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: Notification
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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: 55121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2022
• 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