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

Model Number	21-7395-24
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 disposable was not administering the treatment.No patient injury reported.
Additional Manufacturer Narrative
Other text: 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.B3, d4: expiration date and h4 are unknown, d3, g1, and g2 email is: (b)(6).

• Brand Name: CADD ADMINISTRATION SETS - 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: 17037179
• Report Number: 3012307300-2023-05921
• Device Sequence Number: 12376862
• Product Code: FPA
• UDI-Device Identifier: 10610586027543
• UDI-Public: 10610586027543
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• 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
• Report Date (Section B): 02/01/2024

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: 21-7395-24
• Device Catalogue Number: 21-7395-24
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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