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

Catalog Number 730365

Device Problem No Apparent Adverse Event (3189)

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

Event Date 06/15/2022

Event Type  malfunction  

Event Description

End user states that sealed poly bags inside insulin syringe box with lot 54033 expiration date 04/25/2026 are filled with a 9 count of syringes instead of 10 count.

Manufacturer Narrative

Initial trend analysis for lot 54033 was conducted, no malfunctions were found.This is the only complaint for lot 54033.Further investigation will be conducted to determine the root cause of complaint.

Manufacturer Narrative

The manufacturing process has revealed a deficiency in the automatic packing matching.To solve this process problem, stainless steel guide grooves will be added to the conveyor belt.

Event Description

End user states that sealed poly bags inside insulin syringe box with lot: 54033 expiration date 04/25/2026 are filled with a 9 count of syringes instead of 10 count.

• 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: 14789232
• MDR Text Key: 294601036
• Report Number: 3005798905-2022-03065
• 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: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 730365
• Device Lot Number: 54033
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/15/2022
• 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