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

Model Number 720200

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that on january 17 the button was bought and a change was made as it has been done for 18 years.At night on february 13th they stated that it was evident that the button was rising.They observed the side where the ball is inflated had no water and when leaving more upwards the button it was observed that the ball is broken.They proceeded to hold the button with micropore so that it does not come out completely avoiding the closure of the skin.The patient was taken to the emergency department on day 14 for an ultrasound and endoscopy which showed that the patient does not have any malformation to cause the rupture of the balloon.They changed the probe.

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 issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Three photos were provided for evaluation and the reported issue was confirmed.A corrective and preventive action has been initiated to further address the reported issue.

• Brand Name: BALLOON SLG 20FR X 2.0CM
• Type of Device: 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: 16573483
• MDR Text Key: 312024001
• Report Number: 9612030-2023-03644
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• 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: 2115322764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2023
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male