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

Catalog Number 827555

Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

End user reports that syringe cannulas feel dull during injection.

Manufacturer Narrative

Initial trend analysis for lot 58225b was conducted, no malfunctions were found.This is the only complaint for lot 58225b.Further investigation will be conducted to determine the root cause of complaint.

Manufacturer Narrative

Retained lot number 58225b were investigated for needle sharpness test and visual inspection.All retained lot samples passed investigation tests, no abnormalities found.

Event Description

End user reports that syringe cannulas feel dull during injection.

• 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: 16314788
• MDR Text Key: 309369791
• Report Number: 3005798905-2023-03096
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

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: 827555
• Device Lot Number: 58225B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 03/28/2023
• 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
• Patient Outcome(s): Hospitalization