MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14 FR X 1.7 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	714170
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2022
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 and tube was removed on (b)(6) 2022.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
One decontaminated sample was received at the cardinal health site.A visual and functional inspection according to product specification was conducted by inflating the balloon with water and a leak was detected from a pinhole in the middle part of the globe.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.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition reported by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A sample analysis could not be performed since no photographs nor actual sample/s were received for evaluation.Based on the present information, and since no photo sample was provided and no actual sample was received; a possible root cause cannot be determined.The reported complaint could not be confirmed nor related to a manufacturing process.Based on historical review, a formal corrective/preventative action capa was generated to the supplier (scar) as corrective action of reported condition.

• Brand Name: BALLOON SLG 14 FR X 1.7 CM
• 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: 16585645
• Report Number: 9612030-2023-03647
• Device Sequence Number: 4681586
• Product Code: KNT
• UDI-Device Identifier: 10884521010659
• UDI-Public: 10884521010659
• 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: 714170
• Device Catalogue Number: 714170
• Device Lot Number: 2115322364
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 03/16/2023; 03/16/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/12/2023; 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