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

Model Number 21-7220-24

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/17/2020

Event Type  malfunction  

Event Description

It was reported that the connector tube was sectioned during the night, not known when nor how, but the tube was cut in two and the medication was dripping.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received for evaluation; however, a review of the manufacturing process was performed.No discrepancies were detected during visual inspection.No discrepancies were found during the inspection test.No root cause could determine since the complaint could not be confirmed since no samples or pictures were received for evaluation.Operator of device is patient/consumer.Initial reporter also sent report to fda is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

• 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; building ap16-1; minneapolis, MN 55442
• MDR Report Key: 15360860
• MDR Text Key: 305357529
• Report Number: 3012307300-2022-17832
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028339
• UDI-Public: 30610586028339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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: 3676600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• 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