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

Model Number	21-7323-24
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cadd administration sets - flow stop might have contributed to causing an infusion issue and a high-pressure error.It was also reported that when the tubing is used without the anti-siphon valve it works fine.The patient did not receive the entire amount of chemotherapy due to this issue, but there were no adverse events reported.When the tubing was changed, medication was administered and completed as intended.
Additional Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11407858
• Report Number: 3012307300-2021-01714
• Device Sequence Number: 14295826
• Product Code: FPA
• UDI-Device Identifier: 10610586039614
• UDI-Public: 10610586039614
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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 Expiration Date: 10/22/2025
• Device Model Number: 21-7323-24
• Device Lot Number: 4066501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1