MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 18 FR X 2.3 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	718230
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation because the device was discarded.
Event or Problem Description
Customer reports: three days after the gastrostomy button was implanted in the patient, it came out.The balloon lost water and it was evident that there was a leak in the part of the balloon's filling duct.The product could not be sent since it was contaminated.
Additional Manufacturer Narrative
The device history record for each lot affected was reviewed and showed that the manufacturing and inspection was performed as per applicable procedures and validated process.All inspection results were within acceptable criteria as per established sampling plan levels and quality procedures.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.

• Brand Name: BALLOON SLG 18 FR X 2.3 CM
• 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: 19385603
• Report Number: 9612030-2024-00071
• Device Sequence Number: 11767235
• Product Code: KNT
• UDI-Device Identifier: 10884521011151
• UDI-Public: 10884521011151
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/29/2024

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: 718230
• Device Catalogue Number: 718230
• Device Lot Number: 2324710764
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 05/29/2024
• 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