MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7059-24
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the disposable under delivered or a complete non-infusion of medication using the hct bags and disposable.Patient not affected.No patient injury reported.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Device evaluated, visual inspection performed and results were no damage or other defects were detected on the sample.The reported issue was not duplicated, no discrepancies were detected on the sample, the test successfully passed with a result within spec 0.645 percent thus, the failure mode reported is not confirmed.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.D3, g1, and g2 email is:(b)(6).

• Brand Name: CADD ADMINISTRATION SETS WITH FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16919004
• Report Number: 3012307300-2023-05643
• Device Sequence Number: 6910297
• Product Code: FPA
• UDI-Device Identifier: 10610586020421
• UDI-Public: 10610586020421
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K990083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2024

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 Model Number: 21-7059-24
• Device Catalogue Number: 21-7059-24
• Device Lot Number: 4354745
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 01/05/2024
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 07/12/2023; 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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