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

Catalog Number	21-7361-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a leakage issue due to complete disconnection of the luer lock.There was unknown patient involvement.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: 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 reportable information becomes available.
Additional Manufacturer Narrative
D3: mfg establishment name, city, country; corrected.D9: date received by mfg; 2/4/2025.Device evaluation: one photo and five new samples were received for device analysis.Functional testing and visual inspection of the samples and photo was performed.No leaks were observed on any of the five samples.The customer reported complaint was confirmed with the photo provided.On the other hand the reported complaint could not be replicated with the five returned new samples.

• 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 MN ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21229608
• Report Number: 3012307300-2025-01071
• Device Sequence Number: 18215972
• Product Code: FPA
• UDI-Device Identifier: 15019517191738
• UDI-Public: (01)15019517191738(17)281005(10)4434713
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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 Catalogue Number: 21-7361-24
• Device Lot Number: 4434713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown