MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 16FR X 2.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	716200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the tube was inserted on (b)(6) 2023 and the burst balloon was found on (b)(6) 2023.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.The device history record review could not be performed since no lot number was provided from customer complaint report, and no photo/actual sample with a lot number was received.The affected component is produced by an external supplier; our assembly process only consists of a pick and place operation for this material.The affected component is produced by an external supplier; our assembly process only consists of 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 2.0CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 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: 17187843
• Report Number: 9612030-2023-03736
• Device Sequence Number: 14904551
• Product Code: KNT
• UDI-Device Identifier: 10884521011007
• UDI-Public: 10884521011007
• 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
• Report Date (Section B): 07/05/2023

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: 716200
• Device Catalogue Number: 716200
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown