MAUDE Adverse Event Report: CARDINAL HEALTH 2565 REPLOGLE CATH 10 FR; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	8888256503
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.
Event or Problem Description
Customer reports: there was an incident with a replogle catheter.This involved a tear in the material, which we use as a connecting element.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.
Additional Manufacturer Narrative
Based on the information available to us, the device history record review could not be reviewed since no lot number was provided from the customer.The physical sample was not returned; however, an image was submitted for evaluation.Based on this analysis, a blue tube (pigtail) with a mark can be observed confirming the reported issue.In order to determine a root cause, a gemba walk was done at the manufacturing facility focusing on the manufacturing equipment and process, however the root cause is undetermined.As a corrective/preventative action, personnel production received an awareness notification about the reported condition.The manufacturing site will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.Updated section h6: investigation findings - previously reported as code 213 should be code 180.Updated section h6: investigation conclusions - previously reported as code 67 should be code 4315.Updated section h10: additional manufacturer narrative - additional information added.

• Brand Name: 2565 REPLOGLE CATH 10 FR
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• 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: 17322378
• Report Number: 9612030-2023-03759
• Device Sequence Number: 5537193
• Product Code: BSY
• UDI-Device Identifier: 10884527006427
• UDI-Public: 10884527006427
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 10/20/2023

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: 8888256503
• Device Catalogue Number: 8888256503
• 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: 07/04/2023
• Supplement Date Received by Manufacturer: 07/04/2023; 07/04/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/20/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown