MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 16FR X 1.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	716150
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the probe was being used by a child who detected the leakage of food.Additional information received stated the leak is located in the tube where it meets the end that stays outside the body.There was a small crack.There was no patient harm.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date was added.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 reported condition.The dhr review showed that all acceptance criteria inspections, per established sampling levels, were within acceptable limits during the production process.One photo was provided for evaluation.A broken tube in the upper part is confirmed.Based on the present information, an exact root cause cannot be determined.Based on historical review, a corrective and preventative action (capa) was generated to the supplier of the product to further investigate this issue.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 16FR X 1.5CM
• 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: 16156912
• Report Number: 9612030-2023-03521
• Device Sequence Number: 20711759
• Product Code: KNT
• UDI-Device Identifier: 10884521010987
• UDI-Public: 10884521010987
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/16/2023

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: 716150
• Device Catalogue Number: 716150
• Device Lot Number: 2016112264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/16/2023
• Date Device Manufactured: 06/16/2020
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown