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

Catalog Number 830165

Device Problems Break (1069); Material Fragmentation (1261); Product Quality Problem (1506); Dull, Blunt (2407)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Production records investigated and production records analyzed for lot #53874.The testing showed no indication of abnormalities or malfunction at time of production.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports that the plunger inside the syringe from lot #53874 is difficult to pull.User also reports that the cannula appears to have burrs when pulled out of the insulin vial.

Manufacturer Narrative

Retained lot number 53874 was investigated for plunger slide performance, penetration force test and production records were researched.No abnormalities or malfunctions occured during manufacturing.The manufacturer recommended that when using viscous product when injecting to use a larger gauge.

Event Description

End user reports that the plunger inside the syringe from lot 53874 is difficult to pull.User also reports that the cannula appears to have burrs when pulled out of the insulin vial.

• Brand Name: EASY TOUCH
• 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: 13369680
• MDR Text Key: 287206353
• Report Number: 3005798905-2022-03036
• 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: 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: 830165
• Device Lot Number: 53874
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2022
• 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