MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH. 24 FR BX10

Model Number 211-24

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/22/2022

Event Type  malfunction  

Event Description

Customer reports: during placement of the tube it was difficult to remove the guide from the drain.The blue head of guide was detached causing the pain from the movement.There is no patient injury.Per additional information received on 6/23, the component did not detach inside the patient.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) review confirms that the lot was manufactured to meet all blueprint specifications and quality requirements.No photographs or product sample/s were provided for evaluation therefore the reported condition could not be confirmed.The root cause and corrective actions could not be identified without a sample to evaluate.

• Brand Name: TROCAR CATH. 24 FR BX10
• Type of Device: TROCAR
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14834330
• MDR Text Key: 302959986
• Report Number: 1282497-2022-10697
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: NC
• 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
• Report Date: 09/14/2022

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: 211-24
• Device Catalogue Number: 211-24
• Device Lot Number: 202003380X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 09/14/2022
• 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