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 Bacterial Infection (1735); Cellulitis (1768)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

No product was returned.If the product is returned, smiths medical will reopen this complaint for further investigation.Due to the fact that no lots of p/n 21-7230-24 were scheduled to be manufactured in the near future, a review of the manufacturing process for p/n 21-7231-24, l/n 3949528 was conducted by quality engineer on (b)(6) 2020 in order to verify that there are no situations or practices that could create the event as described in "description of non-conformance".Both products are manufactured with the same manufacturing procedures, process controls and inspections.No problems revealed in engineering.

Event Description

Information received a smith medical cleo infusion set was added in treating a patient who developed erythema, swelling and pain at the infusion site along cause a fever.The patient was hospitalized for bacteria infection.No further information at this time.Infection of skin erythema is caused by for foreign body injected at site.This may be related to aseptic technique or device encountering contamination before injecting.Cellulitis can or may lead to sepsis, which is high risk infection and deterioration.This event is serious injury reportable as the device added in treatment.

• 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: 9951895
• MDR Text Key: 187378886
• Report Number: 3012307300-2020-02890
• 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,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: SET INFULIN 6MM/INSERTER/42 BUCKLE
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3675103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2020
• 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): Hospitalization