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

Model Number MX4311L

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2023

Event Type  malfunction  

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 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.

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
• 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: 16540926
• MDR Text Key: 311291341
• Report Number: 3012307300-2023-02429
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688507761
• UDI-Public: 10351688507761
• 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
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 12/08/2023
• 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