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

Device Problem Crack (1135)

Patient Problems Diarrhea (1811); Headache (1880); Dizziness (2194)

Event Type  malfunction  

Event Description

Pt reports with last titration headache, diarrhea, and lightheadedness which resolved after several days.Pt also experienced weight loss since starting veletri and feels she is "too thin." pt reports that due to weight loss cadd legacy pouch no longer fits her body and she cannot use over the shoulder due to "shoulder issues." pt reports that in her last shipment of dme, she had a defective invision + connector and tubing set which cracked and had to be swapped out.No other info.Reported (b)(6) by pt/caregiver.

• Brand Name: CADD EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8527465
• MDR Text Key: 142499042
• Report Number: MW5085962
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1