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

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Information was received indicating that this extension set came apart during infusion.No adverse patient effects were reported.

Manufacturer Narrative

Device evaluation: one picture of smiths medical cadd administration set was received and it can be observed an asv valve detached from the tube; it is not possible to appreciate if there are marks of solvent in the tube.No testing or thorough inspection could be performed because no samples were provided for evaluation.Based on the evidence, the complaint was confirmed, and the problem source of the reported to be manufacturing.

• Brand Name: CADD® CADD® EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7593368
• MDR Text Key: 110848673
• Report Number: 3012307300-2018-02108
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2018
• Patient Sequence Number: 1