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

Lot Number 57X503

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Type  malfunction  

Event Description

Inbound.Patient reported six week history of problems with leaking at hole in filter of cadd legacy extension set 60 inch minibore with 0.2 micro filter lot number 57x503.Patient verbalized concerns with not getting full sose, possible contamination and risk of blood infection.Patient reported she has also returned previous leaking tubings.No further details provided.Diagnosis or reason for use: pph.Is the product compounded: no.Is the product over-the-counter: no.

• 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: 7482425
• MDR Text Key: 107348105
• Report Number: MW5076982
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 57X503
• 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: 0
• Patient Weight: 59