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	07/21/2019
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
Date of event: (b)(6) 2019.
Additional Manufacturer Narrative
One administration set was returned for evaluation.Visual inspection of the device found it to be in good physical condition.Device underwent functional testing which included a leak test; no discrepencies were found.The reported customer complaint has not been confirmed.A review of the manufacturing process shows quality samples 15 units at an interval of two hours, prior to placing product in bag, in order to verify that parts are free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts, or other workmanship defects that can affect assembly function or appearance while no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• 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: 9111232
• Report Number: 3012307300-2019-04862
• Device Sequence Number: 3588180
• Product Code: FPA
• UDI-Device Identifier: 10610586021480
• UDI-Public: 10610586021480
• Combination Product (Y/N): N
• 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): 02/11/2020

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: 09/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 12/07/2020; 01/14/2020
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 01/06/2020; 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1