MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 20FR X 3.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	720300
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: vivisol srl (rome) recently received a report from the home of the patient (b)(6) by his/her daughter (b)(6) that the kangaroo skin level balloon was found emptied and punctured, out of the insertion point and onto the patient's body.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the device will not be returned for evaluation because it has been discarded.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on august 10, 2018.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.However, a supplier corrective action request has been opened to address the reported condition.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 20FR X 3.0CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 18171938
• Report Number: 9612030-2023-03864
• Device Sequence Number: 7652711
• Product Code: KNT
• UDI-Device Identifier: 10884521011311
• UDI-Public: 10884521011311
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/19/2024

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: 720300
• Device Catalogue Number: 720300
• Device Lot Number: 1827415864
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 11/17/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/06/2024; 01/19/2024
• 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