MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7062-24

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Event Description

Information was received indicating that during use, it was noted that a smiths medical cadd extension set snapped apart and the patient noticed that his backpack was wet.No patient consequences were reported.No adverse effects were reported.

Manufacturer Narrative

A1-4: patient demographics provided.Patient weight and age marked as unknown.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9519980
• MDR Text Key: 177397975
• Report Number: 3012307300-2019-06979
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020452
• UDI-Public: 10610586020452
• Combination Product (y/n): N
• PMA/PMN Number: K942046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2023
• Device Model Number: 21-7062-24
• Device Catalogue Number: 21-7062-24
• Device Lot Number: 3733180
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1