MAUDE Adverse Event Report: CARDINAL HEALTH R ANG THOR CATH 32FR; CATHETER AND TIP, SUCTION

Model Number	8888571059
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the patient side of the chest tube had a plastic piece lodged inside the tube that should have been removed during manufacturing.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
H4 device manufacturing date was added.The device history record (dhr) was reviewed showing no discrepancy.Two pictures and one sample were received for evaluation.A visual inspection showed loose contamination (punch burr) in the catheter.The reported condition was confirmed.The root cause was determined to be that during the puncture, the vacuum was not working.Based on the root cause, a visible and audible alarm was installed to identify when there is no vacuum.In addition, a quality alert was issued to the manufacturing personnel.This complaint will be used for tracking and trending purposes.

• Brand Name: R ANG THOR CATH 32FR
• 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: 17956754
• Report Number: 9612030-2023-03837
• Device Sequence Number: 17922185
• Product Code: JOL
• UDI-Device Identifier: 10884521060937
• UDI-Public: 10884521060937
• 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): 01/03/2024

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: 8888571059
• Device Catalogue Number: 8888571059
• Device Lot Number: 2301037864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown