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

Model Number	21-7061-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer facility phone number: (b)(6).
Event or Problem Description
Information was received indicating that a smiths medical administration set was leaking when connected to a three-way stopcock as the customer attempted to infuse medial fluid (physiological saline solution) using a syringe before use.There was no patient injury.
Additional Manufacturer Narrative
Other, other text: h3: one cadd extension set with part number 21-7061-24 was received in used condition, decontaminated, without its original packaging inside a plastic bag with additional components (syringe and a luer adapter).The sample was visually inspected at a distance of 12? to 16? under normal conditions of illumination.No discrepancies were found per visual inspection.The sample was tested with a syringe and water to look for the leak complaint.It was confirmed fluid, fluid leaked through male luer.Relevant documents were reviewed and deemed adequate and correct with respect to testing and inspection activities.Based on the analysis conducted in the sample provided, the failure could not be reproduced, therefore, the occurrence for this failure condition could be caused by incorrect tube bond engagement, less than 0.25?.The cause of the issue was attributed to manufacturing.

• 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: 10482775
• Report Number: 3012307300-2020-08959
• Device Sequence Number: 17158818
• Product Code: FPA
• UDI-Device Identifier: 10610586020445
• UDI-Public: 10610586020445
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: No Information
• Device Model Number: 21-7061-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 10/11/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1