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 Codes	Abdominal Distention (2601); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: there is an issue with the replogle suction catheter.The replogle was in place at the start of the rn's shift and was found occluded; it would not aspirate or flush with air.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.A sample analysis could not be performed since no photographs or samples or were provided for evaluation.A root cause could not be attributed to a manufacturing/production process.Current process controls are executed in accordance with product specifications to meet quality acceptance criteria.The manufacturing facility will continue monitor the process, customer complaints and feedback notifications for any adverse trends that require immediate attention.In case of a repeated issues and/or reoccurrence, new investigation for the specific events would be carried out for each case.
Event or Problem Description
Additional information was obtained on (b)(6) 2022 during a phone conversation with nurse bleiler in which she stated that the baby experienced a lot of abdominal distention as a result of the occlusion because the device was not suctioning.The device was replaced and the baby was suctioned with no further medical intervention required.
Additional Manufacturer Narrative
Section b3: - describe event or problem - additional information was received on 4/14/22 and the event description has been updated.Section h6: - health effect - clinical code: initially, this was coded as 4582 however additional information has been received therefore the coding has been updated to code 2601.Section h6: - health effect - impact code: initially, this was coded as 2199 however additional information has been received therefore the coding has been updated to code 4629 & 4627.Section h6: - medical device problem code - initially, the added code 1146 was not included however additional information has been received therefore the code has been added.

• 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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13938962
• Report Number: 9612030-2022-03196
• Device Sequence Number: 4813773
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2022

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
• Was Device Available for Evaluation?: Yes
• 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; 03/25/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/13/2022; 04/15/2022
• 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