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 Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.
Event or Problem Description
It was reported that extension tubing was attached to a needleless connector on one end and to a manifold with two ongoing medications, heparin and precedex, on the other end.The nurse turned the patient and saw that the extension tubing, connected to the stopcock, had disconnected or "popped off." a large puddle of liquid was found on the patient's bed, and it is unclear how long the patient had been without medication.There was no medical intervention and patient harm.
Additional Manufacturer Narrative
Neither samples nor pictures were received for the analysis of this complaint.The reported issue could not be confirmed by investigation as no samples nor pictures were provided by the customer.Without the return of the used samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.A device history review was performed, and no discrepancies or anomalies were observed during the manufacturing of this lot.
Additional Manufacturer Narrative
D9: date returned to mfg.: 6/24/2025 h3 and h6.Codes: updated.Updated device evaluation: one used sample of the suspected device/product was received.Functional testing could not be performed as the tubing detached from component stopcock when preparing for leak testing.A visual inspection shows remains of solvent all around its outer surface, evidence of the bonding of components.The complaint was confirmed however, a probable cause could not be determined.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• 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 MN ; MX
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 22066240
• Report Number: 1526863-2025-00057
• Device Sequence Number: 18528743
• Product Code: FPK
• UDI-Device Identifier: 10351688507532
• UDI-Public: (01)10351688507532(17)280113(10)6082808
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2025

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: MX43860
• Device Lot Number: 6082808
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 08/07/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/26/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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