MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX FOUR-WAY STOPCOCK W/ STD BORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX522L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 or Problem Description
It was reported that the connection part where the syringe was attached was leaking/spewing fluids, including copious amounts of blood.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: one unused component was returned in its original packaging.The component was water leak tested and passed.It cannot be determined what caused the reported leak without the affected component.The complaint cannot be confirmed.Three nonconformances were identified during the manufacturing of the affected lot.Each nonconformance was sorted and reinspected per appliable procedures.No actions are planned to be taken at this time, but icu medical continues to track and trend complaints to escalate issues as needed.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.

• Brand Name: MEDEX FOUR-WAY STOPCOCK W/ STD BORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19986930
• Report Number: 1526863-2024-00079
• Device Sequence Number: 20647357
• Product Code: FPA
• UDI-Device Identifier: 10351688506825
• UDI-Public: (01)10351688506825(17)261003(10)4436692
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2026
• Device Catalogue Number: MX522L
• Device Lot Number: 4436692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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
• Patient Sex: Unknown