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

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Headache (1880); Swelling (2091)

Event Type  Injury  

Event Description

Pt attempted to increase dose but had to reduce dose due to headache.Pt reports one side of neck swollen which occurred 3 days after placement of iv line.Pt has discussed with md.Pt has f/u evaluation.Pt reports connection between tubing and cassette keeps getting unscrewed.No other info available.Reported to (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: 8964972
• MDR Text Key: 156767567
• Report Number: MW5089557
• Device Sequence Number: 2
• 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: 08/27/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2019
• Patient Sequence Number: 1