MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASY TOUCH; SAFETY SYRINGE LUER LOCK

Catalog Number 802015

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 05/15/2022

Event Type  malfunction  

Event Description

A complaint was received via email from the (b)(4) regarding a dosage concern of item 802015, lot 54471 expiration date 08/10/2026 when used with the covid-19 vaccine.This complaint is in regards to the small rubber piece on the end of the plunger inside the barrel.The user's report that; "when drawn up to.3mg as directed, the dosage is not.3 mg, it is less due to the extra plunger." also, the shape of the plunger is causing an inaccurate measurement of the covid-19 vaccine".

Manufacturer Narrative

No device was returned for testing.Retained lot number 54471, expiration date 08/10/2026 was investigated.A tolerance capacity test from the reserved samples resulted in no abnormality found in the safety syringe from lot 54471.

• Brand Name: EASY TOUCH
• Type of Device: SAFETY SYRINGE LUER LOCK
• 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: 14522645
• MDR Text Key: 292811193
• Report Number: 3005798905-2022-03062
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/27/2022

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: Health Professional
• Device Catalogue Number: 802015
• Device Lot Number: 54471
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 05/27/2022
• 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