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

Catalog Number 830365

Device Problems Shipping Damage or Problem (1570); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

End-user called in and reported that they opened a ploybag and found the syringe caps had fallen off.The end-user was stuck by one of the uncapped insulin syringes.

Event Description

End-user called in and reported that they opened a ploybag and found the syringe caps had fallen off.The end-user was stuck by one of the uncapped insulin syringes.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• MDR Report Key: 10788529
• MDR Text Key: 244163088
• Report Number: 3005798906-2020-02971
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K1012178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 830365
• Device Lot Number: 50445
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1