MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7359-24

Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

Patient Problem Chemical Exposure (2570)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

Patient called into the clinic to inform staff that the 5fu pump he has was beeping "air in line" patient was told to come to clinic and he arrived about 5:30pm.Tubing was found to have air and chemo was leaking from connection site closest to pump and had leaked on patient's clothes and inside the bag carry on bag provided for pump.5fu tubing was disconnected.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 15121225
• MDR Text Key: 296785831
• Report Number: 15121225
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027406
• UDI-Public: (01)10610586027406
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7359-24
• Device Lot Number: 4257018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Sex: Male