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

Catalog Number 21-7230-24

Device Problem Migration (4003)

Patient Problems Skin Discoloration (2074); Alteration In Body Temperature (2682)

Event Date 01/20/2019

Event Type  malfunction  

Manufacturer Narrative

According to the report the sample was discarded.

Event Description

Information was received that during use of this smiths medical cadd cleo infusion sets, "the plastic end of the cleo set broke off in the patient's arm".It was reported that the site had been in for 4 days.According to the report "the patient developed a temperature and the site became reddened".Reported that surgical consult was ordered to cut out the plastic tip and site had to be sutured.No additional adverse event reported.

Event Description

The reporter stated the cannula broke "at the base of cannula" where it attaches to the infusion site.The reporter confirmed no photographs of the product were available.When clinician was asked about potential causes of the reported event, the clinician stated they determined the location of the infusion site (back of patient's arm) would have "frequently rubbed against the bed because patient was quite mobile".The clinician also stated the site was "left in for 4 days" which "may have contributed" to the cannula break.

• Brand Name: CADD CLEO INFUSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8377668
• MDR Text Key: 137407067
• Report Number: 3012307300-2019-00858
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• Combination Product (y/n): N
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/07/2023
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3619906
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention