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

Model Number 21-7230-24

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

It was reported when the healthcare professional pulled the device back from the insertion site it was found that the needle did not retract and was still sticking out.No patient injury was reported.

Manufacturer Narrative

A product sample was received for evaluation.The sample was received without the base.A test could not be performed due to the fact that the samples received for evaluation were previously used.Any attempt to reprocess the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance.The root cause could not be determine since the complaint could not be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Operator of the device is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD CLEO INFUSION 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: 15564635
• MDR Text Key: 306643459
• Report Number: 3012307300-2022-20007
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-7230-24
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3965585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1