MAUDE Adverse Event Report: BD BD PHASEAL; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number 515003

Device Problem Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 08/10/2017

Event Type  malfunction  

Event Description

Unable to slide the injector into the connector.Second injector obtained and worked fine.

• Brand Name: BD PHASEAL
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BD; 5859 farinon dr; ste 200; san antonio TX 78249
• MDR Report Key: 6886334
• MDR Text Key: 87019184
• Report Number: 6886334
• 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: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/21/2017,08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2019
• Device Model Number: 515003
• Device Catalogue Number: 515003
• Device Lot Number: 1702108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1