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

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Spontaneous call.Spoke with patient who stated that she had fever and infection, and she made mistake and used one of the new cassettes, so she currently has an expired cassette.Informed patient to discard the cassette that is expired and continue using the new cassettes for infusion.Patient also mentioned that she is having problems with her extension set tubing.She had leakage twice last week through the filter, but the leakage stopped when she replaced the tubing.No other information provided at this time.Extension set lot number and expiration date not provided.Did the reported product fault occur while in use with the patient? yes, did the product issue cause or contribute to patient or clinical injury? no, infection and fever was, before the leakage problem end not related.If yes, was any medical intervention provided? no, infection and available for investigation? no, did we [mfr] replace the tubing? yes, did the patient have additional tubing they were able to switch to? yes, if was, the patient able to successfully continue their infusion? yes, if no, what was she patient instructed to do in able to continue their infusion? n/a, is the infusion life-sustaining? yes.What is the outcome of the event? resolve.Resolved? yes, ongoing? n/a.Reported to (b)(6) bypatient/ caregiver.

• Brand Name: CADD -EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12518612
• MDR Text Key: 273302126
• Report Number: MW5104160
• 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
• Type of Report: Initial
• Report Date: 09/20/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1