MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7230-24

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Itching Sensation (1943); Discomfort (2330); Swelling/ Edema (4577)

Event Date 02/02/2020

Event Type  malfunction  

Manufacturer Narrative

No device was received to perform an investigation.The following operations were reviewed, in order to verify that the operations were properly performed, also records were reviewed, in order to ensure that they complied with good manufacturing practices (gmp) requirements and with required procedures.The assemble base with cannula to inserter operation was reviewed to ensure that the cannula was properly assembled; no discrepancies were found.The operators that perform critical operations such as bond skin adhesive film onto flange of sleeve and the skin adhesive inspections using a monitor were all certified.The operators were performing the visual inspection of the adhesive using the skin adhesive inspection as per procedure.Four samples of the reported lot number were taken from the production floor and tested for in process testing and no discrepancies were found.Visual inspection of 32 samples from a different lot number were taken from the production line and were visually inspected in order to verify that the spring was not released.No discrepancies were detected.The retractor assemblies were 100 percent visually inspected by the production personnel to assure that the needle was properly threaded.Production personnel verified 100 percent that parts were not damaged (including scratches) or distorted or warped.Quality personnel verified 100 percent that the needle tip was up, and the blunt end was fully seated and verified the length while still in the needle hub on the pallet.No root cause could be determined, as no samples or pictures were received for evaluation.No corrective actions were initiated since the complaint could not be confirmed.A device history record (dhr) review was performed.No problems or issues were identified during the dhr review.D5 is unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the patient experienced a reaction at the infusion site located in the abdomen.Edema, itching, and discomfort were noted.Further information indicated that there was no indication that the patient was prescribed antibiotics for this issue.No injury was reported.

• Brand Name: CLEO 90 INFUSION SET
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15353876
• MDR Text Key: 305703802
• Report Number: 3012307300-2022-17686
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/19/2023
• Device Model Number: 21-7230-24
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3675103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 09/04/2022
• 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
• Patient Sequence Number: 1