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

Lot Number 3983998

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Information was received indicating that upon opening a smiths medical cadd extension set was noted to be leaking.Event did not occur during use with a patient.No adverse effects were reported.

Manufacturer Narrative

Other, other text: nine cadd extension sets were received for investigation.Functional testing was performed using a hydrostat vessel.During the test, the water passed through the tube and filter without problems.No leaks were detected during the test.The complaint was not confirmed.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 11076213
• MDR Text Key: 223716993
• Report Number: 3012307300-2020-12770
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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: Lay User/Patient
• Device Expiration Date: 05/24/2015
• Device Lot Number: 3983998
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/24/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR