MAUDE Adverse Event Report: CARDINAL HEALTH 8FR REPLOGLE SUCT CATH; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	8888256529
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: a new replogle was required and dislodged with extubation and fell onto the bed.The device could not be flushed with saline or air; resistance was felt.A second new replogle tube was obtained and checked to see if it would flush prior to insertion.The product would flush but there was increased resistance, possibly a narrowing inside the inlet port.The inlet port appeared to be closed further along the device.A third device was obtained and checked prior to insertion and there were no issues therefore the device was used.There was no harm to patient at this time.The three devices were from the same lot.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality requirements.A sample analysis was not possible since no photographs or physical samples were provided for evaluation.Based on the present information, and without a sample to evaluate, a possible root cause cannot be determined, therefore, the reported complaint could not be confirmed nor related to a manufacturing process.All associated lot documentation was carefully reviewed; no issues or discrepancies were found related to the reported complaint.There are guidelines to be followed in the ifu (instructions for use) detailing the insertion procedure of the replogle suction catheter.The current process is running according to product specifications meeting quality acceptance criteria.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.As part of a containment action, a notification was issued to the personnel involved in the production of the device to heighten awareness of the reported condition.
Additional Manufacturer Narrative
Investigation findings has been updated from code 4248 - usage problem identified to 4247 - appropriate term/code not available.Investigation conclusions has been updated from code 19 - cause traced to user to 4315 - cause not established.

• Brand Name: 8FR REPLOGLE SUCT CATH
• 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: 14919109
• Report Number: 9612030-2022-03305
• Device Sequence Number: 13961432
• Product Code: BSY
• UDI-Device Identifier: 10884527006410
• UDI-Public: 10884527006410
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/06/2022

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: 8888256529
• Device Catalogue Number: 8888256529
• Device Lot Number: 2131350364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 07/04/2022; 07/04/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 09/01/2022; 09/06/2022
• 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