MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX STOPCOCKS; STOPCOCK, I.V. SET

Model Number MX4341L

Device Problem Obstruction of Flow (2423)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported that the stopcock primed and added to primary line.Free flows well but once hooked up to pump and pump programmed reads downstream occlusion and increased pressure.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.One unopened sample was returned.The sample was not the sample that was reported as defected for occlusion.This was known due to the fact that the sample was returned in the sterile packaging unopened.Upon opening the sample the part was visually inspected under 10x magnification and found no signs of occlusion or intermittent occlusion in the part.Next, the sample was taken to the lab and water leak tested which includes priming each port of the sample.All testing came back positive with no occlusions or leaks.Next, the sample was tested per m.90 for plug/body hole alignment.This test requires that a 0.105 inch gauge pin be able to pass through all ports and plug holes with no greater than a 1/2 pound (lb) push.All holes were clear for the pin to pass through and required no pressure to enter.The root cause of the reported issue was found to be after review of the component, no signs of occlusion were found present.This sample was not the reported sample however so this does not mean that the sample(s) that were used as the customer facility did not experience this defect.If the defective components could be returned a more thorough investigation could be completed on the actual affected part.Based on the report, it is possible that the pump that is being used has a low backpressure alarm that could result from any interference in the line.Interferences could come in many forms.One such interference could be a diameter size change in the line due to the fluid traveling through the line having to change from one diameter size down to another smaller line, this would result in increased fluid velocity through the smaller line but may have a small back pressure effect from the wall section that is hit at the end of the larger diameter section.Recommendation was to check all lines and components for occlusion.

• Brand Name: MEDEX STOPCOCKS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13282312
• MDR Text Key: 285065103
• Report Number: 3012307300-2022-00980
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: 10351688507648
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX4341L
• Device Catalogue Number: MX4341L
• Device Lot Number: 4183215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1