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

Catalog Number	21-7222-24
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Twenty-six samples were received along with one picture for evaluation.Visual inspection found the samples were decontaminated; six samples without its original packaging and twenty samples with its original packaging.The picture displayed the television (tv) antenna defect; the complaint was confirmed.However, there was no observed antenna or needle defect in the twenty-six samples inspected.According with the procedure, it should be verified that the needle is properly threaded inside of the cannula and that the tip of the cannula is flush or below at least one of the three needle heels.Root cause was determined to be a lack of following the procedure, pm-450 rev.113 section 2.13.An awareness notification was made to production personnel in order to explain the importance of adhering/following the procedure pm-450 rev.113.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
Event or Problem Description
It was reported that the client had high blood glucose levels with multiple catheters and when the needle was triggered, it perforated the catheter.No patient injury was reported.

• Brand Name: CLEO
• Common Device Name: 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: 15369109
• Report Number: 3012307300-2022-18070
• Device Sequence Number: 1726354
• Product Code: FPA
• UDI-Device Identifier: 10610586028359
• UDI-Public: 10610586028359
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/20/2025
• Device Catalogue Number: 21-7222-24
• Device Lot Number: 3984449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown