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

Model Number	21-7357-24
Medical Device Problem Codes	Product Quality Problem (1506); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
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 that during an infusion, the tubing detached from the spike portion, causing drug to be lost.No patient injury reported.
Additional Manufacturer Narrative
A sample was received without its original packaging.Visual inspection showed that the spike was separated from the tube and residual solvent was observed around the tube tip.The device was received in damaged condition, pull testing could not be performed on the sample.An analysis was performed using components taken from a process using three different scenarios to reproduce the failure mode.The third scenario was found to be out of specification, and it was concluded that the insertion of the tube inside the bag spike was not performed correctly.Based on the testing scenarios and analysis of the received sample the root cause was found to be that during the manufacturing process the sample insertion depth was out of specification, an incorrect insertion of the tube to the spike pocket.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Production personnel were notified of the failure mode.

• 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: 16591463
• Report Number: 3012307300-2023-02903
• Device Sequence Number: 20070465
• Product Code: FPA
• UDI-Device Identifier: 10610586027390
• UDI-Public: 10610586027390
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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: Health Professional
• Device Model Number: 21-7357-24
• Device Catalogue Number: 21-7357-24
• Device Lot Number: 4330851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 134 KG