MAUDE Adverse Event Report: BD PHASEAL; SET, IV, FLUID TRANSFER

Device Problems Disconnection (1171); Leak/Splash (1354)

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

Event Date 11/24/2016

Event Type  malfunction  

Event Description

Patient had chemotherapy infusing for 15 minutes when parents let rn know that iv tubing became disconnected.The iv tubing disconnected from the phaseal system.Chemotherapy was on patient clothing but none noted on the patient's skin.Patient skin cleansed.Phaseal system replaced and infusion restarted.There were no other issues with iv tubing or phaseal.Rn manager spoke with the rn who was caring for the patient.Rn had just completed the circle prime process, disconnected the phaseal system after the circle prime.She took it into the patient's room and hooked it up to the patient.Approximately 15 minutes into the infusion, rn was called into the room because the tubing had become disconnected.Rn is not sure if something happened to cause the tubing to become loose during the circle priming process or if it came apart on its own.One item of each lot number was pulled for all lot numbers for the phaseal that was in the medication room.The lot#s were 1603012, 1603002, and 1603008.Carefusion smartsite infusion set for the alaris pump lot # 16096192 was also pulled from service.

• Brand Name: PHASEAL
• Type of Device: SET, IV, FLUID TRANSFER
• Manufacturer (Section D): BD; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 6212275
• MDR Text Key: 63533212
• Report Number: 6212275
• Device Sequence Number: 1
• Product Code: LHI
• 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: Other
• Type of Report: Initial
• Report Date: 11/30/2016

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
• 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: 11/30/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CAREFUSION SMARTSITE INFUSION SET LOT # 16096192
• Patient Age: 7 YR