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

Lot Number 3675081

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Event Description

Inbound, pt calling to report that he has now had 3 cadd 60" ext set tubing from lot #3675081 have a "dimple" in them and cause me hi pressure alarms.Pt reports light refracts differently through where the dimple is located and looks as though a line is going down the tubing from it.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: 8203118
• MDR Text Key: 131897336
• Report Number: MW5082666
• Device Sequence Number: 3
• 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: 12/05/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3675081
• 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: 90