MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 12FR X 2.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 712200

Device Problem Break (1069)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the device was inserted on (b)(6) 2022 and there was a hole/break in the shaft (between top and balloon) found on (b)(6) 2022.

Manufacturer Narrative

The device history record (dhr) was reviewed.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.Per the provided information, a sample is available, but the device has not yet been received for evaluation therefore we were unable to perform functional and visual evaluations to confirm the reported issue or determine a root cause.However, a corrective and preventive action has been initiated to address the reported issue.Additionally, once the sample is received, the investigation will be reopened and updated further, if needed.

Manufacturer Narrative

One sample was received for evaluation.A visual inspection and functional test was performed per procedure.The balloon was inflated with water and a break was detected at the top of the tube.The reported issue was confirmed.A corrective and preventive action was initiated to further investigation this issue.

• Brand Name: BALLOON SLG 12FR 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: 16040409
• MDR Text Key: 308374730
• Report Number: 9612030-2022-03498
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 712200
• Device Catalogue Number: 712200
• Device Lot Number: 2000203264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• Type of Device Usage: A
• Patient Sequence Number: 1