MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX MICRO BORE SINGLE LINE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	536040
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the extension tubing was repeatedly beeping occluded.Patient iv was checked and was not occluded at time.New extension tubing utilized.No patient harm.
Additional Manufacturer Narrative
Other text: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Three devices were returned for investigation.Two of the devices returned were not made by icu medical.The 3rd device was tested for occlusion by water leak test.The test confirmed that the device was occluded at the male luer.Visual inspection of the luer shows excess solvent causing the occlusion.This device is assembled on our microbore machine.A maintenance work order history shows that corrective maintenance was completed for "excess solvent on the male side," which would explain the occlusion.Icu medical regularly analyzes complaint data and trends and will take further actions accordingly.A 2-year complaint history found no other complaints about the same issue.For all enquiries or follow-up questions related to the record, do not use ( b)(6) located in sections g.1., please direct those to the following: (b)(6).D.4.Full udi number: (b)(4).

• Brand Name: MEDEX MICRO BORE SINGLE LINE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17761405
• Report Number: 3012307300-2023-08981
• Device Sequence Number: 20499412
• Product Code: FPA
• UDI-Device Identifier: 10351688516336
• UDI-Public: 10351688516336
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K831087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: Health Professional
• Device Expiration Date: 08/17/2025
• Device Catalogue Number: 536040
• Device Lot Number: 4319620
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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 Age: 14 YR
• Patient Sex: Female