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

Model Number	21-7062-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that during use of this smiths medical cadd extension sets, the set snapped apart during infusion.It was reported that the pump was in the patient's backpack and the backpack got wet prior to the patient's mother noticed that the infusion sets had snapped apart.No adverse effects were reported.
Additional Manufacturer Narrative
Device evaluation- one used set was returned for evaluation.Review of manufacturing records for lot 3733181 revealed no discrepancies or anomalies, but visual examination of the returned set confirmed a breakage had occurred.A review of the manufacturing process was carried out in response to this observation.During this review, assembly and packaging operations were checked to ensure no objects or components were present that could damage tubing with none found.A random sampling of 32 sets from manufacturing stock were also examined to check for any workmanship defects or damage, and all of the sets passed.The reported issue could not be attributed to a manufacturing issue.

• Brand Name: CADD EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9205718
• Report Number: 3012307300-2019-05460
• Device Sequence Number: 11520872
• Product Code: FPA
• UDI-Device Identifier: 10610586020452
• UDI-Public: 10610586020452
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/09/2023
• Device Model Number: 21-7062-24
• Device Catalogue Number: 21-7062-24
• Device Lot Number: 3733181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 01/19/2020
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1