MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7391-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse noticed medication leaking under the pump, from the bottom of the tubing cassette and onto the floor.The pump volume to be infused (vtbi) did not match the amount left in the medication bag.A new cadd pump was set up and new infusion started.Approximately 2 hours later, the patient reported he was still in pain.The cadd screen showed the patient was receiving medication.The physician was notified and discontinued the infusion order.When the nurses were aspirating medication from the tubing to waste, they found medication in the cassette area.Upon inspection, it looked as if the tubing was punctured by the clip of the cassette.No patient harm reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Additional Manufacturer Narrative
D9: product received date 2/25/2025.H3/h6: one device was returned for evaluation.As received no damage or anomalies were observed.In attempt to replicate clinical use, admin set was attached to medical bag and inserted into a pump.The set was primed with 10 ml.No alarms, leakage, or difficulties priming were observed.The set was then leak tested to 45psi.A leak was observed between the pump tube outgoing tube junction.The bond was pulled apart and inspected.Solvent channel was observed.The complaint of punctured tubing cannot be confirmed.During investigation a leak was observed at the pump tube outgoing tube junction.The probable cause is due to a solvent application coverage error during manufacturing.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20455485
• Report Number: 3012307300-2024-11195
• Device Sequence Number: 12540299
• Product Code: FPA
• UDI-Device Identifier: 10610586027512
• UDI-Public: (01)10610586027512(17)290404(10)6005541
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 21-7391-24
• Device Lot Number: 6005541
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 10/07/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/24/2024; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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 Age: 58 YR
• Patient Sex: Unknown