MAUDE Adverse Event Report: MHC MEDICAL PRODCUTS, LLC. EASY TOUCH; INSUIN SYRINGE

Catalog Number 627155

Device Problem Device Issue (2379)

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

Event Date 05/14/2018

Event Type  malfunction  

Event Description

Soiled syringe reported prior to use.

• Brand Name: EASY TOUCH
• Type of Device: INSUIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODCUTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnati, OH 45240
• MDR Report Key: 7636574
• MDR Text Key: 112286932
• Report Number: 3005798905-2018-00987
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 627155
• Device Lot Number: 47602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1