MAUDE Adverse Event Report: CARDINAL HEALTH 8FR REPLOGLE SUCT CATH; CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION

Model Number	8888256529
Medical Device Problem Codes	Complete Blockage (1094); Decrease in Suction (1146)
Health Effect - Clinical Code	Abdominal Distention (2601)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: there is an issue with the replogle suction catheter.The nursing staff tried one this morning and it was defective.Additional information was received on 4/14/22 stating that the replogle was found occluded; it would not aspirate or flush with air.The device was replaced and no further medical intervention was required.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed, and no discrepancy was found according to the reported condition.There were no samples or photographs submitted for review and investigation.Based on the limited information received, the reported complaint could not be confirmed nor related to a manufacturing process.All associated lot documentation was carefully reviewed with no issues or discrepancies were found related to the reported complaint.Based on the analysis, the observed occurrence of harm improbable which is below the range of the expected occurrence rate therefore corrective actions are not deemed necessary at this time.

• Brand Name: 8FR REPLOGLE SUCT CATH
• Common Device Name: CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14118515
• Report Number: 9612030-2022-03221
• Device Sequence Number: 4234225
• Product Code: KDH
• UDI-Device Identifier: 10884521000711
• UDI-Public: 10884521000711
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: 2126437964
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 05/07/2022
• 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