MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 24FR X 3.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 724300

Device Problem Material Perforation (2205)

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

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the 24fr3cm nutriport that was placed in a young adult on (b)(6) 2022 had dislodged.The customer stated there is a hole at the base of the balloon.They will replace with a new tube.No patient harm reported.

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.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Per the complaint record, a sample is available.However, at the time of this letter, the sample has not yet been received at the manufacturing site.Once the sample is received at the manufacturing site, the investigation will be updated.Based on the present information available and since the sample has not yet been received and analyzed, the reported issue could not be confirmed.However, a notification was forwarded to the supplier of this component.The root cause and any corrective and preventative actions will be determined by the supplier.We will also continue to monitor the process, customer complaints and feedback notifications for any adverse trends that require immediate attention.

Manufacturer Narrative

One sample was received for evaluation.Visual and functional inspections were performed per procedure; the balloon was inflated with water and a leak was detected in the lower part of the tube.No rupture was found in the balloon.A notification was forwarded to the supplier of this component.The root cause and any corrective and preventative actions will be determined by the supplier.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 24FR X 3.0CM
• 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: 14644567
• MDR Text Key: 301643997
• Report Number: 9612030-2022-03273
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521011458
• UDI-Public: 10884521011458
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 724300
• Device Catalogue Number: 724300
• Device Lot Number: 1923226764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• Type of Device Usage: A
• Patient Sequence Number: 1