MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX HI FLO STOPCOCK; STOPCOCK IV SET

Model Number MX4341L

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown, no information has been provided to date.G4: 510k 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 there were "a few breaks" in the middle of a procedure.No adverse patient effects were reported by the customer as it was discovered prior to administering chemotherapy drugs.The issue has occurred with multiple patients.

• Brand Name: MEDEX HI FLO STOPCOCK
• Type of Device: STOPCOCK IV SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 17052835
• MDR Text Key: 316848880
• Report Number: 3012307300-2023-90101
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: 10351688507648
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2023

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: MX4341L
• Device Catalogue Number: MX4341L
• Device Lot Number: 4348742
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• 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