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

Catalog Number 828155

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

No device returned for testing.Production records analyzed for lot #53724 and trend analysis conducted.No abnormalities were detected during manufacturing process and no other complaints found for lot #53724.

Event Description

End user reports that box of syringes purchased at a pharmacy sealed with the circular sticker seal contained only 5 poly bags.

Manufacturer Narrative

No device returned for testing.Production records analyzed for lot 53724 and trend analysis conducted.No abnormalities were detected during manufacturing process and no other complaints found for lot 53724.Documentation provided to prove that individual boxes are sealed after packing process.

Event Description

End user reports that box of syringes purchased at a pharmacy sealed with the circular sticker seal contained only 5 poly bags.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN 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: 13369606
• MDR Text Key: 287205434
• Report Number: 3005798905-2022-03035
• 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,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• 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: 53724
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1