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

Model Number 21-7359-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 01/14/2021

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical administration set was leaking.There were no reported adverse events.

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device, the customer reported condition was not confirmed.No fault found.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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11307396
• MDR Text Key: 231148552
• Report Number: 3012307300-2021-01099
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027406
• UDI-Public: 10610586027406
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

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
• Device Operator: No Information
• Device Model Number: 21-7359-24
• Device Lot Number: 4010267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 04/04/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1