MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX STANDARD BORE EXTENSION SET W/ 3-WAY STOPCOCK; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Catalog Number	MX252L
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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.
Event or Problem Description
It was reported that the stop cock came off the end of the iv tubing.The product fault occurred during infusion while in use with a patient.The tubing was changed out.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
One device of lot number 6016716 was received for investigation.The investigation only occurred on the stopcock due to the inability to decontaminate the tubing.Visual inspection found the inner surface of stopcock assembly shows indications of a complete solvent bond.No gaps appear in the haze created by the solvent on the bonding region and the tubing was fully inserted.No adverse trends have been identified related to this issue.A device history review found no nonconformances.

• Brand Name: MEDEX STANDARD BORE EXTENSION SET W/ 3-WAY STOPCOCK
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• 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: 21560612
• Report Number: 1526863-2025-00013
• Device Sequence Number: 9602045
• Product Code: DTL
• UDI-Device Identifier: 10351688508232
• UDI-Public: (01)10351688508232(17)270508(10)6016716
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K782168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: Health Professional
• Device Catalogue Number: MX252L
• Device Lot Number: 6016716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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 Age: 63 YR
• Patient Sex: Unknown
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White