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

Catalog Number	21-7364-24
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported by a nurse that the treatment was not delivered the day before.Only a small portion of the bag was administered.There was patient involvement, and no human harm reported.
Additional Manufacturer Narrative
H3: neither samples nor pictures were received for analysis.Without the return of the used samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD HIGH-VOLUME ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; tijuana MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21069299
• Report Number: 3012307300-2025-00210
• Device Sequence Number: 3493473
• Product Code: FPA
• UDI-Device Identifier: 15019517191776
• UDI-Public: (01)15019517191776(17)271025(10)4337553
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 21-7364-24
• Device Lot Number: 4337553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown