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

Model Number	21-7105-24
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that there was a delivery issue that occurred three times with a fentanyl infusion.The allegation of malfunction is on the cadd cassette reservoir.The patient reported that two units have a "faulty minute av bubbles" in the line despite flushing.The issues reported were air bubbles and downstream occlusion.There was no report of patient injury or medical intervention as a result of this event.
Additional Manufacturer Narrative
One sample was received in used condition.During testing, water passed through the tube without problems.No bubbles or occlusions were observed.The complaint could not be confirmed.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.
Additional Manufacturer Narrative
Other, other text: one sample was received in used condition.During testing, water passed through the tube without problems.No bubbles or occlusions were observed.The complaint could not be confirmed.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 EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 9263229
• Report Number: 3012307300-2019-05187
• Device Sequence Number: 11400358
• Product Code: FPA
• UDI-Device Identifier: 10610586022715
• UDI-Public: 10610586022715
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2021

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: Health Professional
• Device Expiration Date: 10/18/2023
• Device Model Number: 21-7105-24
• Device Catalogue Number: 21-7105-24
• Device Lot Number: 3713021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 04/04/2021; 04/04/2021
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 04/28/2021; 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1