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

Model Number	720200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: there was a balloon disruption after 16 days of use.
Additional Manufacturer Narrative
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 from the customer complaint.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A sample analysis was not possible because there were no photographs or physical samples provided for evaluation.Without a sample analysis, we are unable to confirm the reported condition.The root cause and action plan will be documented through a formal corrective/preventative action (capa) which has been initiated with the supplier to address the reported condition to mitigate any further occurrences.
Additional Manufacturer Narrative
The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no deviations and no non-conformances initiated with this lot code.One decontaminated device within the original packaging and lot 192915064 was received for evaluation.A visual inspection was performed according to procedure.Additionally, a functional test was conducted by inflating the balloon with water and a leak was detected in the tubing of the balloon, but there was no rupture found in the balloon.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 action is currently ongoing.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: 14633865
• Report Number: 9612030-2022-03271
• Device Sequence Number: 14932151
• Product Code: KNT
• UDI-Device Identifier: 10884521011274
• 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,Followup
• Report Date (Section B): 09/12/2022

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: 1929415064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 05/23/2022; 05/23/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 06/10/2022; 09/12/2022
• 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: Male