MAUDE Adverse Event Report: CAREFUSION 303, INC STOPCOCK ALARIS SET

Catalog Number 42382-01

Device Problems Break (1069); Disconnection (1171)

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

Event Date 03/06/2017

Event Type  malfunction  

Event Description

While changing the patient's lines that were connected to the patient's uvc (umbilical venous catheter), the iv tubing broke off into the stopcock that was attached to the uvc.Rn turned the stopcock off to the baby and contacted dr.To come and assess the situation.Dr.Put on a new stopcock and new iv tubing was attached to the patient.Rn was unable to remove iv tubing from the stopcock of a uvc so she used a pair of hemostats in order to loosen the connection.It was unable to loosen so again tried using a gloved hand and the tubing at the connection of broke of into the stop.As mentioned dr.Was called to assist with changing the stopcock.Unable to determine if it was a malfunction of iv tubing/stopcock or force that was used.The next night, a similar incident occurred with a different rn and a different baby.Rn was changing patient's lines and was trying to disconnect iv tubing from the patient's uvc.While trying to disconnect the tubing, it broke off into the stop cock attached to the uvc.The stopcock was turned off to the patient while the stopcock was changed and the new tubing was attached.For the second incident, it broke exactly the same without the hemostat.

• Brand Name: STOPCOCK ALARIS SET
• Type of Device: STOPCOCK
• Manufacturer (Section D): CAREFUSION 303, INC; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 6460109
• MDR Text Key: 71718026
• Report Number: 6460109
• Device Sequence Number: 1
• Product Code: FMG
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 42382-01
• Device Lot Number: 3231161
• 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: 03/22/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2017
• 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: NO OTHER DEVICES; NO OTHER THERAPIES