MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX MICRO BORE SGL LINES EXT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	536040
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that leakage at luer lock connection was observed.Patient involvement is unknown.
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.H3 - other: device has not been returned to date.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
D9: 03/17/2025.G1: corrected.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3: one device was returned for analysis.Functional and visual tests were performed, but the reported issue was not duplicated.The cause of the reported issue was not determined as no issue was identified through testing.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: MEDEX MICRO BORE SGL LINES EXT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 21229357
• Report Number: 1526863-2025-00002
• Device Sequence Number: 8325931
• Product Code: FPA
• UDI-Device Identifier: 10351688516336
• UDI-Public: (01)10351688516336(17)251120(10)4337450
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K831087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2025

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: Other
• Device Expiration Date: 11/20/2025
• Device Catalogue Number: 536040
• Device Lot Number: 4337450
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 02/28/2025; 10/31/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/26/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown