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

Model Number	MX4341L
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 3way stopcock started leaking while in use of iv medications.No additional information.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2022-03688
• Device Sequence Number: 11876510
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: 10351688507648
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K953573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 05/11/2022; 02/16/2023
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/12/2022; 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown