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

Model Number 21710624

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Spontaneous call: pt reports she needed her extension tubing replaced.Noticed that it was leaking from the middle and she has replaced it since then.She does replace more often, she thinks if she goes longer than the one day, it may leak again.Troubleshot with pt but replacing tubing order for pt.Did the reported product fault occur while in use with a patient? yes; did the product issue cause or contribute to patient or clinical injury? no; if the actual device available to be returned for investigation? no, she provided lot 3983998.Did we [mfr] replace device? yes; did the patient have a backup device they were able to switch to? yes, if yes, was the patient able to successfully continue their infusion? yes; reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10704286
• MDR Text Key: 212291557
• Report Number: MW5097328
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21710624
• Device Lot Number: 3983998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1