MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS MULTI LINE WITH STOPCOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MX6812

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423); Connection Problem (2900)

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

Event Type  malfunction  

Event Description

It was reported that there was an emergency in the operating room, and blood could not pump through the extension tubing.They experienced leaking and were hard to connect to the insertion port.There has been no report of observable clinical symptoms or a change in symptoms, or adverse affects identified in the patient.

Manufacturer Narrative

Udi and device lot number are unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Manufacturer Narrative

Health impact, and evaluation codes: updated.No product was returned therefore device analysis could not be performed.A device history record (dhr) review could not be completed as the lot number was unknown.No action was taken and if the product is returned, the complaint will be re-opened for further investigation.

• Brand Name: MEDEX EXTENSION SETS MULTI LINE WITH STOPCOCK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 16150279
• MDR Text Key: 308556435
• Report Number: 3012307300-2023-00418
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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 Catalogue Number: MX6812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 06/18/2023
• Supplement Dates FDA Received: 06/21/2023
• 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