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

Catalog Number 21-7220-24

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2021

Event Type  malfunction  

Event Description

Information was received regarding a cadd cleo infusion set.It was reported that there were missing cannulas on 3 cleo sets.The patient called her nurse because she was blocked.When the catheter was removed, there was no cannula.They did not know if the cannula was missing at the time of insertion or if it remained in the patient's body.There were no skin marks observed.Apomorphine was being administered at 5mg/ml.It is unknown if there was patient, or clinician injury associated with these occurrences.No further details provided at this time.

Manufacturer Narrative

Other text: corrected data b1, corrected data: corrected data b1-product problem.

• Brand Name: CLEO
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12746598
• MDR Text Key: 279923626
• Report Number: 3012307300-2021-10651
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028335
• UDI-Public: 10610586028335
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 4053889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female