MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14 FR X 1.2 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 714120

Device Problem Unintended Deflation (4061)

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

Event Date 01/23/2023

Event Type  malfunction  

Event Description

The customer reported the balloon leaked.No intervention was required other than replacing the product.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: the device history record (dhr) review showed 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.One sample was received for evaluation.A visual inspection and a functional test were performed.The balloon was inflated with water and a leak was detected in the lower part of the tube.The reported issue was confirmed.A walk through of the process was carried out.Current process and controls were found to be followed correctly.No abnormal conditions were found that could trigger the reported condition.A corrective and preventative action (capa) was generated to the supplier to further investigate this issue.This complaint will be used for tracking and trending purposes.

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.One sample was received for the evaluation.A visual inspection and functional testing were performed.The balloon was inflated with water and a leak was detected.A corrective and preventative action (capa) was opened to further investigate this issue.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 14 FR X 1.2 CM
• 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: 16245780
• MDR Text Key: 308492460
• Report Number: 9612030-2023-03536
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 714120
• Device Catalogue Number: 714120
• Device Lot Number: 2109720164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• Type of Device Usage: A
• Patient Sequence Number: 1