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

Model Number	720200
Medical Device Problem Code	Unintended Deflation (4061)
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 that at the time of the procedure, the nurse saw that the balloon was punctured.The nurse put the air pressure at 5 ml and sometime later, it dropped to 3 ml then to 2 ml.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One sample was received for evaluation.A visual inspection according to procedure, and a functional test was performed according to product specification.When the balloon was filled with 5ml of water, no leak was observed, it was left inflated with water for the second day and when the water was removed with a syringe it only contained 3ml of water.The root cause and action plan will be documented through a formal corrective/preventative action (capa) which has been initiated to address the reported condition to mitigate any further occurrences.This complaint will be closed with no further action and 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: 15918913
• Report Number: 9612030-2022-03481
• Device Sequence Number: 6723141
• Product Code: KNT
• UDI-Device Identifier: 20884521011271
• UDI-Public: 10884521011274
• 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): 01/30/2023

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: 720200
• Device Catalogue Number: 720200
• Device Lot Number: 2025230064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown