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

Model Number	21-7036-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number is not known at this time.
Event or Problem Description
Information was received indicating that cadd administration sets - non flow stop leaked from the filter.There were no adverse events reported.
Additional Manufacturer Narrative
Additional information: h6, h10: device evaluation: one smiths medical cadd administration set was returned for analysis in a used condition.Visual inspection of the pump showed delamination at the join of the filter with the tube in the sample received.During functional testing, a leak was observed fleeing from the air vent of the filter in the sample, the reported complaint was able to be confirmed.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.

• 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: 10714394
• Report Number: 3012307300-2020-10504
• Device Sequence Number: 3899426
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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 Model Number: 21-7036-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 12/27/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1