MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX INFUSION STOPCOCK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MX5341L

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

It was reported that when administering medication through 3 way stop cock, medication was not delivered and spilled out due to crack in stopcock.No patient injury was reported.

Event Description

Additional information received via (email): patient information not available.There is no further adverse impact other than stated in initial report.A device serial number was also reported but could not be verified.

Manufacturer Narrative

Other text: additional event information received.A serial number was provided, but it did not match to any lot numbers in our systems.A device history record (dhr) review cannot be performed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the reporting manufacturer will reopen this complaint for further investigation., corrected data: h6: correction: event problem patient code: 4582-no clinical signs, symptoms or conditions (b)(4).

• Brand Name: MEDEX INFUSION STOPCOCK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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; 14th floor, north tower; minneapolis, MN 55442
• MDR Report Key: 15163762
• MDR Text Key: 297272732
• Report Number: 3012307300-2022-14649
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688506788
• UDI-Public: 10351688506788
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX5341L
• Device Catalogue Number: MX5341L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1