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

Model Number 21710624

Device Problem Fluid/Blood Leak (1250)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Spontaneous: patient reports medication was leaking out of her tubing.Patient changed her tubing and cut a piece of the leaking tubing near her site, was able to return infusion without any issues.Patient reported flushing and no other symptoms.Author advised patient to take blood pressure and blood pressure reported within normal range.Product lot number unknown.Patient will see her prescriber next week.Prescriber notified of event via email.Nursing has been emailed to provide further assistance.No other details known.Reported to cvs/caremark by pt/caregiver.

• Brand Name: CADD EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 15283119
• MDR Text Key: 298701105
• Report Number: MW5111685
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 21710624
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2022
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female