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

Catalog Number 831165

Device Problems Nonstandard Device (1420); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  malfunction  

Event Description

Cannula detached from syringe in end-user's arm while insulin was being administered.End-user went to er.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODCUTS, LLC.; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODCUTS, LLC.; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: jennifer seiple ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 8820074
• MDR Text Key: 152034721
• Report Number: 3005798905-2019-02805
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091474
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 831165
• Device Lot Number: 45435A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2019
• 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