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 Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

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.

• Brand Name: CADD
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10478596
• MDR Text Key: 205247542
• Report Number: 3012307300-2020-08918
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191714
• UDI-Public: 15019517191714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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: 08/03/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 66