MAUDE Adverse Event Report: BD PHASEAL; SET, I.V. FLUID TRANSFER

Model Number C 35-0

Device Problems Disconnection (1171); Obstruction of Flow (2423); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/28/2020

Event Type  malfunction  

Event Description

Patient called the rn as the iv pump was beeping.Anther rn went to check the pump and it was showing "partial occlusion," so the rn checked the tubing from top towards patient side.While holding and checking the tubing, the rn noticed that it was disconnected from the hub of hep cap of cvc.Rn called primary rn and cleaned with preventics and reconnected back to the tubing.Then the charge nurse was called and rechecked the tubing/iv and advised to change the optima connector and connect a new one and secure it.A new optima connector was placed.Manufacturer response for iv connector,and injector, qbd phaseal optima (per site reporter).Optima reps from within (b)(6) will be making arrangements to come on-site to round, observe, and discuss with staff.

• Brand Name: PHASEAL
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BD; 5859 farinon dr ste 200; san antonio TX 78249
• MDR Report Key: 10173505
• MDR Text Key: 195740679
• Report Number: 10173505
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: C 35-0
• Device Lot Number: 1910101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10585 DA