MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 16FR X 1.7CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	716170
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the tube was inserted on (b)(6) 2022 and a broken shaft was discovered on (b)(6) 2023 resulting in loss of feed and meds.Start of peristomal erythema.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for the affected lot was review, showed that manufacturing and inspection product was performed as per applicable procedures and validated process.All inspection results were carried out and were within acceptable criteria as per established sampling plan levels quality procedures.A sample was not returned for evaluation, consequently, it was not possible to evaluate it as part of a comprehensive failure investigation.The root cause and corrective actions could not be identified without a sample to evaluate.The affected component is produced by an external supplier; our assembly process only consists in a pick and place operation for this material.According due to similar cases presented in the past, a formal corrective/preventative action (capa) has been opened to document the reported issue.
Additional Manufacturer Narrative
One decontaminated sample was received at the cardinal health site.A visual and functional inspection according to product specification was conducted.It was observed that the union part between the valve and the balloon tube is broken.The affected component is produced by an external supplier; our assembly process only consists of a pick and place operation for this material.The root cause and action plan were initiated to the supplier as a corrective action report (scar).A formal corrective/preventative action report (capa) has been opened to further investigate this issue.

• Brand Name: BALLOON SLG 16FR X 1.7CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 16682608
• Report Number: 9612030-2023-03667
• Device Sequence Number: 8079878
• Product Code: KNT
• UDI-Device Identifier: 10884521010994
• UDI-Public: 10884521010994
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/03/2023

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: 716170
• Device Catalogue Number: 716170
• Device Lot Number: 2121525764
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 04/05/2023; 04/05/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/02/2023; 07/03/2023
• 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