MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD HIGH-VOLUME ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7381
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that a patient experienced the contents of their bag running empty before the intended time.The therapies ranged from tpns with taper dosing to post-chemo hydration with continuous infusions, with the infusions ending as early as an hour to three hours before the expected time.There was patient involvement, but no patient harm/adverse event reported.
Additional Manufacturer Narrative
The device history record of reported lot number 4347394 was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the complaint will be reopened for further investigation.

• Brand Name: CADD HIGH-VOLUME ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22206665
• Report Number: 3012307300-2025-07098
• Device Sequence Number: 15364736
• Product Code: FPA
• UDI-Device Identifier: 10610586027468
• UDI-Public: (01)10610586027468(17)271110(10)4347394
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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 Model Number: 7381
• Device Catalogue Number: 21-7381-24
• Device Lot Number: 4347394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown