MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET 0.2-MICRON FILTER; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 58X056

Device Problems Air Leak (1008); Leak/Splash (1354)

Patient Problem Dyspnea (1816)

Event Type  malfunction  

Event Description

Outbound.Patient informed nurse extension tubing is leaking from the filter.Patient also reports more short of breath than yesterday.Large air bubble noted in cassette attached to patient.No further information available.Lot number: 58x056.

• Brand Name: CADD EXTENSION SET 0.2-MICRON FILTER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 7605160
• MDR Text Key: 111399587
• Report Number: MW5077870
• Device Sequence Number: 0
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 58X056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 83