MAUDE Adverse Event Report: CARDINAL HEALTH STR THOR CATH 12FR; CATHETER AND TIP, SUCTION

Model Number	8888570507
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the chest tube (ct) disconnected from the tubing.The patient's mom pressed the call bell when she noticed, so it is unknown how long it was open to air.Tpa had just been instilled approximately 1 hour previously.There was no increased wob or signs of respiratory distress noted at the time of discovery.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because no lot number was provided.A sample evaluation could not be performed because no sample nor photo was provided.The reported condition could not be confirmed.No abnormal conditions were found that could trigger the reported condition.Based on the present information, no action plan is deemed required.A notification was made to production personnel about the reported condition, with the purpose of raising personnel awareness.This complaint will be used for tracking and trending purposes.

• Brand Name: STR THOR CATH 12FR
• Common Device Name: CATHETER AND TIP, SUCTION
• 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: 18484391
• Report Number: 9612030-2024-00012
• Device Sequence Number: 18425362
• Product Code: JOL
• UDI-Device Identifier: 10884521050815
• UDI-Public: 10884521050815
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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: 8888570507
• Device Catalogue Number: 8888570507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/07/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown