MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7624-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported the upstream occlusion alarm sounded after the giving set run through and one bolus into patient administered.No patient injury reported.
Additional Manufacturer Narrative
One sample was received for evaluation.Visual inspection revealed the sample was received in used conditions without its original packaging, decontaminated and inside in a plastic bag; no damage was detected.Functional testing was performed but the reported issue could not be replicated.No root cause could be determined as no device problem was found.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No action was taken.Email address: (b)(6).Corrected data: h6: health effects.

• Brand Name: CADD ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16776034
• Report Number: 3012307300-2023-04321
• Device Sequence Number: 6670868
• Product Code: FPA
• UDI-Device Identifier: 10610586044748
• UDI-Public: 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
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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 Expiration Date: 12/12/2024
• Device Model Number: 21-7624-24
• Device Catalogue Number: 21-7624-24
• Device Lot Number: 4339180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown