MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE 31G-.5CC-5/16"; SYRINGE, PISTON

Model Number 831565

Device Problems Bent (1059); Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981); Physical Property Issue (3008)

Patient Problem Skin Irritation (2076)

Event Date 02/21/2018

Event Type  malfunction  

Event Description

User allegedly had syringes that were not working appropriately.User described that "when removing the cap, the needle bends and breaks when sticking into the stomach it leaves a bump".

• Brand Name: EASYTOUCH INSULIN SYRINGE 31G-.5CC-5/16"
• Type of Device: SYRINGE, PISTON
• 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: 7606720
• MDR Text Key: 111231187
• Report Number: 3005798905-2018-02247
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 831565
• Device Lot Number: 44594B & 55027
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1