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

Lot Number 3635420

Device Problem Leak/Splash (1354)

Patient Problems Anxiety (2328); No Code Available (3191)

Event Type  malfunction  

Event Description

Inbound patient reports that pump extension tubing is leaking at filter.Mother called back on (b)(6) 2018 to voice she and patient are experiencing anxiety, frustration, worry about the leaking tubing.States it happened again yesterday, tuesday (b)(6) 2018.She is voicing frustration that the leaking tubing is still occurring.Wants it fixed, and states she and her daughter do not understand why it is not fixed after 3 months.Confirmed it is still the issue of the slow leak at the back of the imbedded filter in the tubing.No further details provided.

• 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: 8014221
• MDR Text Key: 125756502
• Report Number: MW5080868
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3635420
• 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: 64