MAUDE Adverse Event Report: CARDINAL HEALTH ARGYLE; TROCAR

Model Number 8888561027

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

12fr chest tube placed in infant for a pneumothorax, no marking numbers on chest tube, noticed after insertion.Chest tube replaced with a different chest tube after not in proper position on chest x-ray.Patient stable throughout, no harm.Manufacturer: covidien, argyle trocar catheter 12fr, lot#: 2119531964.All lot numbers in unit pulled.Original package given to apsm.Manufacturer response for argyle trocar catheter 12fr, argyle trocar catheter 12fr (per site reporter).[redacted date] requested mfg item number and to confirm if the whole lot impacted with no markers, can't pull lot in absence of recall.[redacted date] - sample discarded by clinicians, [redacted name] retrieved the original packaging; emailed rep.[redacted date] - pictures of the outer package sent to cardinal; [redacted name] respond to clinical questions.This is cardinal case# (b)(4).

• Brand Name: ARGYLE
• Type of Device: TROCAR
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18551511
• MDR Text Key: 333340855
• Report Number: 18551511
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2023

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 Model Number: 8888561027
• Device Catalogue Number: 8888561027
• Device Lot Number: 2119531964
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1