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

Model Number	716170
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the tube was inserted on (b)(6) 2022 and the valve was found to be leaking.The tube was removed on (b)(6) 2023.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
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.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.
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.One sample from was received for evaluation.A visual inspection and functional test was performed according to product specifications whereas 3 ml.Of water was placed into the balloon and initially, no leak was observed the balloon however after it was left inflated for 2 days, when removing the liquid only 2 ml of water was recovered; a leak defect was confirmed.The affected component is produced by an external supplier; our assembly process only consists of a pick and place operation for this material.Based on historical review, a formal corrective/preventative action capa was generated to the supplier (scar) as corrective action of reported condition.The results of the investigation will be documented through the capa.

• 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 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: 16631865
• Report Number: 9612030-2023-03656
• Device Sequence Number: 5334522
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2023

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: 03/16/2023
• Supplement Date Received by Manufacturer: 03/16/2023; 03/16/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/12/2023; 07/31/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown