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

Model Number 9MM INSERTER/RETRACTOR, 24 BUCKLE AY 0-10/BX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Swelling (2091)

Event Date 04/20/2020

Event Type  Injury  

Event Description

Information was received that during use of this smiths medical cadd cleo infusion sets, the infusion site reaction l side of abdomen, warm to the touch red, and mild discomfort from the patient was noticed.It was reported that the infusion cannula removed, and hospitalization was needed for taking an ultrasound of the impacted area.No additional adverse effects reported.

• 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
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; building ap16-1; minneapolis, MN 55442
• MDR Report Key: 10370091
• MDR Text Key: 201766518
• Report Number: 3012307300-2020-07858
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9MM INSERTER/RETRACTOR, 24 BUCKLE AY 0-10/BX
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3900360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• 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): Hospitalization