MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTATION, INTRAVASCULAR

Model Number	21-7094-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the disposable leaked during the night which led to the replacement of the infusion, initially prepared for 96 hours, with a new 48-hour infusion.No patient injury reported.
Additional Manufacturer Narrative
Other text: d4 (lot number) is unknown; no further information provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
No serial or lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, the reported complaint could not be confirmed and the root cause could not be determined.If the product is returned, this complaint will be reopened for further investigation.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTATION, 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: 16805281
• Report Number: 3012307300-2023-04487
• Device Sequence Number: 1855344
• Product Code: FPA
• UDI-Device Identifier: 10610586025266
• UDI-Public: 10610586025266
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K933390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: Lay User/Patient
• Device Model Number: 21-7094-24
• Device Catalogue Number: 21-7094-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/11/2023
• 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 Age: 18 YR
• Patient Sex: Male
• Patient Weight: 67 KG