MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS - FLOW STOP; SET, I.V. FLUID TRANSFER

Catalog Number	21-7624-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pca set was leaking near the pump cassette.The concern is that the patient has not been receiving the full/any of the dose when pressing it.There was patient involvement, but no human harm reported.
Additional Manufacturer Narrative
E1: phone (b)(6).H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3: one used unit was received at manufacturer and were decontaminated per internal procedures.Currently devices are unavailable for evaluation.If the devices become available, we will file an additional report with our findings.Neither samples nor pictures were received for the analysis of this complaint.No device history record was reviewed since lot number was not provided.The failure mode could not be confirmed by investigation as no samples nor pictures was provided by the customer.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.
Additional Manufacturer Narrative
D9: 13-nov-2024.H3: one used administration set was received for evaluation.The returned product does not match the item number provided by the customer.As received, no damage or anomalies were observed.Functional testing was performed, and no leakage was observed.The complaint of leakage cannot be replicated or confirmed.A lot of history review was not performed as the lot number is unknown.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20343733
• Report Number: 3012307300-2024-10307
• Device Sequence Number: 7895604
• Product Code: LHI
• UDI-Device Identifier: 10610586044748
• UDI-Public: (01)10610586044748
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 21-7624-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 04/17/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/14/2024; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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