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

Lot Number 1820585.

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2018

Event Type  malfunction  

Event Description

Malfunction with the equashield closed system transfer device - female ll connector.After removing the female connector out of the packaging, everything looks correct.After locking the male and female components together then disconnecting them, there seems to be a malfunction with the female component.The needle stays exposed within the female component and it does not allow the male and female components to get reconnected.One nurse reported that some medication was leaking out of the malfunctioned female component upon disconnecting from the male component.We have experienced this malfunction with lot #1820585.

• Brand Name: EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD LLC
• MDR Report Key: 8128831
• MDR Text Key: 129341647
• Report Number: MW5081791
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1820585.
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1