MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH 24FR

Model Number 8888561050

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the blue handle of the trocar has broken off three times in a row.No patient was harmed.

Manufacturer Narrative

The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.No sample was available for evaluation.Without a sample we were unable to perform a thorough investigation to determine the root cause or implement any corrective action.We were unable to confirm the reported condition.No root cause can be determined.A corrective and reported action (cap)a will not be initiated.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Additional information: h6 type of investigation code was added.

• Brand Name: TROCAR CATH 24FR
• Type of Device: TROCAR
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048
• MDR Report Key: 18397915
• MDR Text Key: 331508672
• Report Number: 9611018-2023-00637
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 10884521050785
• UDI-Public: 10884521050785
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

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: 8888561050
• Device Catalogue Number: 8888561050
• Device Lot Number: 23F179FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 12/13/2023; 12/13/2023
• Supplement Dates FDA Received: 01/25/2024; 02/02/2024
• Type of Device Usage: A
• Patient Sequence Number: 1