MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX 4-WAY STOPCOCK EXTENSION SET; TUBING, FLUID DELIVERY

Catalog Number	MX43860
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided 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.
Event or Problem Description
It was reported that the four-way stopcock extension utilized with arterial lines were spontaneously separating where the tubing meets the stopcock.There was a patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Device evaluation: one sample was received.The product was visually inspected under a microscope and it was observed that tube exhibited solvent bonding signature.The solvent signature of this piece was compared against the returned sample and it was observed that the solvent length and signature mark were similar.Therefore, it was concluded that the solvent bonding process of the component from the returned sample was executed correctly.The device history record of the reported lot was reviewed and it was confirmed that no non-conformities were reported during production.

• Brand Name: MEDEX 4-WAY STOPCOCK EXTENSION SET
• Common Device Name: TUBING, FLUID DELIVERY
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19297773
• Report Number: 9616567-2024-00079
• Device Sequence Number: 17887628
• Product Code: FPK
• UDI-Device Identifier: 10351688507532
• UDI-Public: (01)10351688507532(17)261211(10)4440699
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 06/12/2024

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 Catalogue Number: MX43860
• Device Lot Number: 4440699
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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 Sex: Unknown