MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; ADMINISTRATION SET

Model Number 21-7345-24

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Information was received that air is leaking into system after being primed-air rushing into the line through the filter when held above the rest of the tubing and bag.Saline hydration bags delivered (already spiked and primed with tubing) had a significant amount of air in the bags and tubing.No patient injury.It was determined that air was entering the hydration bags through the air eliminating filter in the 7345 tubing.

Manufacturer Narrative

Other, other text: two samples were received (one used) and one underwent functional testing by connecting to water bag.It was noted that no air bubbles were detected; unable to confirm the reported customer complaint.The used sample however was unable to be tested given the condition of the device.

• Brand Name: CADD
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10483600
• MDR Text Key: 205325461
• Report Number: 3012307300-2020-08980
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191714
• UDI-Public: 15019517191714
• Combination Product (y/n): N
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7345-24
• Device Catalogue Number: 21-7345-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 68