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

Model Number	MX4311L
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number, expiration date, and manufacture date are unknown.No information has been provided to date.Protocol number is blank; device is exempt.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 dial was broken or cracked.Drugs were leaking out, not getting to patient, and eventually blood "backed up out the pip" and started dripping onto the floor.There has been no report of patient injury, no observable clinical symptoms, or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Other, other text: h6 - health impact and evaluation codes: updated d3, g1, and g2 email is: regulatory.Responses@icumed.Com device evaluation: analysis details: no product was returned by the customer and no pictures were provided.No lot number was provided.Without the parts or pictures of the parts the investigation cannot go any further.With no lot number, the device history report (dhr) review could not 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 manufacturer will reopen this complaint for further investigation.

• Brand Name: MEDEX HI-FLOW STOPCOCK
• 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: 16540926
• Report Number: 3012307300-2023-02429
• Device Sequence Number: 15256847
• Product Code: FMG
• UDI-Device Identifier: 10351688507761
• UDI-Public: 10351688507761
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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 Model Number: MX4311L
• Device Catalogue Number: MX4311L
• Was Device Available for Evaluation?: No
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown