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

Model Number SET INFULIN 6MM/INSERTER/42 BUCKLE

Device Problem Contamination (1120)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Cellulitis (1768)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

No product was returned.(b)(6).No information on lot number or manufacture provided.

Event Description

Information received a smith medical cleo infusion set described an event where atheroma at infusion site and required medication along with therapy.Diagnoses of this can cause hardening of arteries , build up pf plaque in blood arteries and risk for rupture of blood clot.This may be localized but unknown what exact treatment required or if necrotic tissue developed.Additional information is being sought at this time.This file is serious injury reportable until finding further information revealing event did not cause serious injury.

• 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
• Manufacturer (Section G): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 lane n; minneapolis, mn ; 3833310
• MDR Report Key: 10031099
• MDR Text Key: 190113760
• Report Number: 3012307300-2020-03772
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SET INFULIN 6MM/INSERTER/42 BUCKLE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2020
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other