MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 20FR X 2.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	720200
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
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 client bought a button and it didn't last more than three weeks.The damage it presents is in the lower part, which is the part in the stomach.Additional information received stated the balloon had a hole in it and deflated.
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.A sample analysis could not be performed because no sample was available for evaluation.A video was provided showing where a leak in the balloon was observed.The complaint will be reopened if sample is received.The reported condition was confirmed through the video.The root cause of this issue will be determined by the supplier and will be documented under a supplier corrective action request.Corrective and preventive actions will be performed by the supplier.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 20FR X 2.0CM
• 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: 14999725
• Report Number: 9612030-2022-03313
• Device Sequence Number: 1753168
• Product Code: KNT
• UDI-Device Identifier: 10884521011274
• UDI-Public: 10884521011274
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 08/12/2022

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: 720200
• Device Catalogue Number: 720200
• Device Lot Number: 1822601964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/12/2022
• Date Device Manufactured: 08/21/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown