MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. CADD® HIGH-VOLUME ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7081-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information received that a smiths medical product the cadd® high-volume administration sets, had leakage during infusion of unknown medication.The leakage occurred at the branch site that is marked with a black pen.No adverse patient injuries reported.
Additional Manufacturer Narrative
Device analysis: one smiths medical cadd administration set was returned for analysis.Visual inspection was performed under normal conditions of illumination and no damage nor workmanship defect were detected.During analysis, leak testing was performed using hydrostat vessel to look for unusual functions and no discrepancies were detected; test was successfully passed.Based on the evidence, the complaint was not confirmed, and no fault was found.
Additional Manufacturer Narrative
G4: correct aware date is (b)(6) 2019.

• Brand Name: CADD® HIGH-VOLUME ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9111223
• Report Number: 3012307300-2019-04714
• Device Sequence Number: 1984579
• Product Code: FPA
• UDI-Device Identifier: 10610586021480
• UDI-Public: 10610586021480
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K991599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2020

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: Health Professional
• Device Expiration Date: 03/26/2024
• Device Model Number: 21-7081-24
• Device Catalogue Number: 21-7081-24
• Device Lot Number: 3780632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 12/07/2019; 07/21/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 01/06/2020; 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1