MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX SMALL BORE EXTENSION LINE W/ FOUR-WAY STOPCOCK; TUBING, FLUID DELIVERY

Catalog Number	MX43860
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stopcock separated at the tubing connection during use.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D5.Other operator of device: operator of device is unknown.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
Three malfunctioning items were reported.
Additional Manufacturer Narrative
Device evaluation: five samples in total were received for investigation, code mx43860 lot 4431399.Four samples unused inside their original package.One sample used outside its original package which was decontaminated.Air, water, and pull tests were completed.The four samples did not exhibit leak condition.The four samples were found within specification for pull test characteristics.The used unit was visually inspected through a microscope and it was observed that there was a lack of solvent on the luer.The reported condition could be related to an inadequate solvent bonding process.The complaint was confirmed for the used device.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.Awareness for failure mode ¿the four-way stopcock extension utilized with arterial lines were spontaneously separating where the tubing meets the stopcock¿ was given to personnel who perform the assembly process.G5 is unknown.

• Brand Name: MEDEX SMALL BORE EXTENSION LINE W/ FOUR-WAY STOPCOCK
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18773031
• Report Number: 9616567-2024-00032
• Device Sequence Number: 17258871
• Product Code: FPK
• UDI-Device Identifier: 10351688507532
• UDI-Public: (01)10351688507532(17)261101(10)4431399
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: Other
• Device Catalogue Number: MX43860
• Device Lot Number: 4431399
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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