MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 18 FR X 2.7 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	718270
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the balloon burst in the patient after being placed 2 weeks prior.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
On (b)(6)2023 it was reported that the suspected medical device information was initially reported incorrectly.The correct information was provided.Sections d1 and d4 were updated.D9 and h3 were also updated.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that the device history record was reviewed and indicated that the product was released accomplishing all quality standards.One sample was returned for evaluation and a leak was detected in the lower part of the tube.A corrective and preventive action has been initiated to further investigate this issue.All information received will be used for further tracking and trending purposes.

• Brand Name: BALLOON SLG 18 FR X 2.7 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: 17394035
• Report Number: 9612030-2023-03772
• Device Sequence Number: 17625065
• Product Code: KNT
• UDI-Device Identifier: 10884521011175
• UDI-Public: 10884521011175
• 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): 09/01/2023

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: 718270
• Device Catalogue Number: 718270
• Device Lot Number: 2121525964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 07/18/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/18/2023; 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male