MAUDE Adverse Event Report: EQUASHIELD MEDICAL LTD. EQUASHIELD SYRINGE CLOSED SYSTEM TRANSFER SYRINGE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Device Problem Structural Problem (2506)

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

Event Date 09/07/2021

Event Type  malfunction  

Event Description

After using the equashield syringe to transfer injectable drug from a vial, needles were inappropriately exposed.Fda safety report id# (b)(4).

• Brand Name: EQUASHIELD SYRINGE CLOSED SYSTEM TRANSFER SYRINGE
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD MEDICAL LTD. ; port washington NY 11050
• MDR Report Key: 12512923
• MDR Text Key: 272918485
• Report Number: MW5104123
• Device Sequence Number: 1
• Product Code: ONB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/17/2021

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1