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

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2024

Event Type  malfunction  

Event 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.

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 Description

Three malfunctioning items were reported.

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
• Type of Device: 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
• MDR Text Key: 336993084
• Report Number: 9616567-2024-00032
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MX43860
• Device Lot Number: 4431399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1