MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14FR X 2.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 714200

Device Problem Break (1069)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the shaft was broken on the skin level balloon device at the top, near to the external bumper.

Manufacturer Narrative

A decontaminated sample was received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the sample, the defect was confirmed; the union part between the valve and the balloon tube was broken.A root cause analysis indicated that this occurred during material processing.A corrective and preventive action has been initiated to address the reported issue.

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.However, a corrective and preventive action has been initiated to address the reported issue.If a sample is received at a later date, this complaint will be reopened for further investigation.

• Brand Name: BALLOON SLG 14FR 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: 18333851
• MDR Text Key: 330579304
• Report Number: 9612030-2023-03877
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 714200
• Device Catalogue Number: 714200
• Device Lot Number: 2223526064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1