MAUDE Adverse Event Report: EQUASHIELD LLC EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Device Problems Difficult to Insert (1316); Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2020

Event Type  malfunction  

Event Description

Equashield closed system device was having a pressure issue.When the syringe was pushed to insert fluid into bag, fluid was not being inserted into the bag and was coming out of the other valve.Fda safety report id # (b)(4).

• Brand Name: EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD LLC; port washington 11050
• MDR Report Key: 10828875
• MDR Text Key: 216340552
• Report Number: MW5097774
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): Y
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Is the Reporter a Health Professional?: Yes
• 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