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

Catalog Number 827155

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978); Scratched Material (3020)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

A health professional, harm reduction director reported on behalf of the users of the syringes that the cannulas "have bent tips and twisted bevels".The syringes appear damaged directly from the unopened box.

Manufacturer Narrative

No device was returned for testing.Initial trend analysis and production records for lot 54732a were inspected, no malfunctioned found, this is the only complaint for lot 54732a.

• Brand Name: EASYTOUCH
• Type of Device: SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 13047615
• MDR Text Key: 285837487
• Report Number: 3005798905-2021-03027
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/20/2021

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 Catalogue Number: 827155
• Device Lot Number: 54732A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 12/20/2021
• 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