MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD M/ML EXTENSION SET 0.2 MICRON; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

Event Type  malfunction  

Event Description

Pt reports having an issue with her tubing slipping off of her invision plus connector.Pt reattached the tubing without issues and stated that she had not been off the medication for more than an hour.Pt states she feels okay and that she is in contact with cnss (b)(6), to find a solution to the issue.No other info is known.Dose or amount: 60 inch, frequency: continuous, route: iv.Dates of use: from (b)(6) 2018 to continuing.

• Brand Name: CADD M/ML EXTENSION SET 0.2 MICRON
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 7650192
• MDR Text Key: 112862441
• Report Number: MW5078144
• Device Sequence Number: 0
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR