MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH 10FR

Model Number 8888561019

Device Problem Failure to Disconnect (2541)

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

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

Customer reports: after inserting a 10fr trocar chest tube into the infant's chest, c.Loughran was unable to remove the stylet/guidewire portion from the chest tube.Multiple attempts were made to remove the tube but it was not possible.The chest tube had to be removed and a new chest tube was inserted.Intervention was required for placement of the new chest due to the equipment malfunction of the original one.The patient was monitored throughout the procedure and no acute changes were noted by the providers and bedside staff.The chest tube was placed in a biohazard bag at the bedside, if needed for further investigation.Per additional information received on 1/24/23, the end of the device appeared to be tapered correctly and the wire insert also appeared to be embedded correctly.There was no patient injury and the medical intervention required was to pull and replace the chest tube.The patient has no issues regarding this incident.

• Brand Name: TROCAR CATH 10FR
• Type of Device: TROCAR
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16237130
• MDR Text Key: 309010447
• Report Number: 9612030-2023-03535
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 10884521029255
• UDI-Public: 10884521029255
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

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: 8888561019
• Device Catalogue Number: 8888561019
• Device Lot Number: 74A2202318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1