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

Model Number SET INFULIN 6MM/INSERTER/42 BUCKLE

Device Problems Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)

Patient Problem Cellulitis (1768)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Information received a smith medical cleo infusion set caused patient to have abdominal cellulits.Cellulitis can be superficial on the epidermis of the skin, which is non life threatening.This file is reportable at this time, as we do not have additional information indicating that the infection is superficial or if intervention was implemented to preclude serious life threatening impairment like infection spreading to sepsis, (b)(6) or any other organism that could invade the body tissue.When follow up indicates other wise.This file is considered serious injury reportable, unless follow up indicates otherwise.

• 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 HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4,; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 lane n; minneapolis, mn ; 3833310
• MDR Report Key: 9973411
• MDR Text Key: 188074065
• Report Number: 3012307300-2020-03056
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2023
• Device Model Number: SET INFULIN 6MM/INSERTER/42 BUCKLE
• Device Catalogue Number: 21-7222-24
• Device Lot Number: 3675103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• 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): Required Intervention