MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET 0.2 MICRON FILTER; FILTER, INFUSION LINE

Lot Number 3607913

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

Inbound, pt stated tubing lot 3607913 was leaking at the filter.Stated did not find the leak until this evening but thinks it had been leaking since this am.Denied symptoms.No further details provided.Diagnosis or reason for use: pph.

• Brand Name: CADD EXTENSION SET 0.2 MICRON FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 7776618
• MDR Text Key: 117138821
• Report Number: MW5079061
• Device Sequence Number: 1
• Product Code: FPB
• 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: 07/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3607913
• 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