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

Catalog Number 829155

Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Physical Property Issue (3008)

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

Event Date 04/30/2018

Event Type  malfunction  

Event Description

Don't work.Incredibly dull.When inserting into the insulin vial, the needle bends & nbsp; they are really tight when drawing the plunger back & nbsp.

• Brand Name: EASY TOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, 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: 7576112
• MDR Text Key: 110507765
• Report Number: 3005798905-2018-00558
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 829155
• Device Lot Number: 45013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2018
• 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: Unknown
• Patient Sequence Number: 1