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

Model Number 21-7220-24

Device Problem Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 01/26/2020

Event Type  malfunction  

Manufacturer Narrative

No device was returned.However, a review of the manufacturing process was conducted by a quality engineer on in order to verify that there are no situations or practices that could create the event.During the verification the following operations were reviewed: inserter assembly operation was audited by the quality engineer and it was performed by the production personnel according to the manufacturing procedures.Training records were reviewed, operators are trained on operation that was performed.Maintenance records from site threader machine was reviewed; no anomalies were detected.Functional test of three samples from cleo production line and tested; after removing the white cap the site was inserted into the insertion pad and no detachment or bents were detected in any of the tested samples.The retractor assemblies are 100 percent visually inspected by the production personnel to assure that the needle is properly threaded.Qc performs an in-process audit at one hour intervals to verify that needle is properly threaded on the retractor assemblies.No root cause could determine since the complaint could not be confirmed since no samples or pictures were received for evaluation.D5 is unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that there was a bent needle in the cannula set.Patient was at home and following insertion of a new cannula and the site became painful.The cannula was checked and it was discovered that it was bent.No medical or surgical intervention was reported.

• Brand Name: CLEO
• 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: 15353790
• MDR Text Key: 305703141
• Report Number: 3012307300-2022-17619
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028339
• UDI-Public: 30610586028339
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2023
• Device Model Number: 21-7220-24
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 3677257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1