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

Catalog Number SE-10/2

Device Problem Disconnection (1171)

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

Event Date 04/06/2019

Event Type  malfunction  

Event Description

Equashield plunger disconnected from rubber stopper during medication draw up in pharmacy.Fda safety report id# (b)(4).

• Brand Name: EQUASHIELD DEVICE
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTRUCTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD LLC; port washington NY 11050
• MDR Report Key: 8573343
• MDR Text Key: 143948212
• Report Number: MW5086316
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: SE-10/2
• Device Lot Number: 1920229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• 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