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

Catalog Number 832041

Device Problems Nonstandard Device (1420); Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

Device was not returned to manufacturer for testing.Production records have been supplied.(b)(4).

Event Description

End-user stated "it seems like the needle inside is gone." the end-user is referring to the cannula inside the syringe barrel.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield, oh
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield, oh
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, oh
• MDR Report Key: 9960028
• MDR Text Key: 187916880
• Report Number: 3005798905-2020-02933
• 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
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 832041
• Device Lot Number: 50078
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• 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