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

Model Number 21-7361-24

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fever (1858); Chills (2191); Shaking/Tremors (2515)

Event Date 04/09/2021

Event Type  malfunction  

Event Description

It was reported the device was in use for saline hydration infusion.The reporter stated the device was found leaking.Reporter stated before leakage was detected patient showed symptoms of muscle pains, cramping, fever, chills and shaking.Reporter received replacement devices with no adverse effects reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4).As a result of warning letter cms (b)(4).Corrected data: h10: a device history review (dhr) was conducted, which indicated all inspections were completed.And no issues were noted, during manufacture.

• Brand Name: CADD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12199772
• MDR Text Key: 262555481
• Report Number: 3012307300-2021-07408
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191738
• UDI-Public: 15019517191738
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7361-24
• Device Catalogue Number: 21-7361-24
• Device Lot Number: 4057950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1