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

Model Number	21-7036-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that cadd administration sets - non-flow stop leaked.The tube was changed to resolve the issue.There were no adverse events reported.
Additional Manufacturer Narrative
Device evaluation- one device was returned for evaluation.The device was given functional testing; this showed leakage at the air vent area of the filter.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.During production, cadd administration sets are 100% visually inspected to ensure filter-to-tube bonds meet with criteria for minimum tube engagement.The devices are 100% inspected for tube back out and tubing delamination.The cadd administration sets are sampled for leak testing at regular intervals during production of every lot number.The investigation determined the most likely cause of the reported issue was damage occurring during use or preparation by user.

• 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: 10950898
• Report Number: 3012307300-2020-12138
• Device Sequence Number: 3150020
• Product Code: FPA
• UDI-Device Identifier: 10610586020186
• UDI-Public: 10610586020186
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K933390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: No Information
• Device Expiration Date: 10/14/2024
• Device Model Number: 21-7036-01
• Device Lot Number: 3886099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 02/14/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1