MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX LARGE BORE - HI-FLO STOPCOCKS; STOPCOCK, I.V. SET

Model Number MX4341L

Device Problem Leak/Splash (1354)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2021

Event Type  Injury  

Event Description

It was reported that the 3way stopcock started leaking while in use of iv medications.No additional information.

Manufacturer Narrative

Device evaluation: 1 device was received for evaluation.Visual inspection noted a crack near the parting line of the a-port.When leak tested, the device leaked from that crack.A review of manufacturing records for the provided lot number was conducted and no issues, work orders or anything related was found during production of this lot.The leakage is confirmed but root cause could not be determined.

Event Description

Information was received indicating that the patient experienced a drop in blood pressure due to the leak.The iv medication used was to keep blood pressure level, however the name of the medication was not provided.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The device appears to have a crack near the parting line on the a-port.Investigation confirmed that the device had a leak at the a-port where the crack is located.The root cause of the reported issue was not able to be determined.Actions were taken to mitigate the reported issue was unknown.No problems or issues were identified during this device history record review.

• Brand Name: MEDEX LARGE BORE - HI-FLO 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: 13563216
• MDR Text Key: 286562076
• Report Number: 3012307300-2022-03688
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: 10351688507648
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K953573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX4341L
• Device Catalogue Number: MX4341L
• Device Lot Number: 4195704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 05/11/2022; 02/16/2023
• Supplement Dates FDA Received: 05/12/2022; 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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
• Patient Outcome(s): Required Intervention