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

Model Number 714200

Device Problem Unintended Deflation (4061)

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

Event Date 11/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the patient receives diet via gastrostomy using a kangaroo nutriport button 14fr /ch x2.0cm installed on (b)(6).2023.On (b)(6).2023 they were informed by the residence that the button was spontaneously expelled.The patient received a nursing visit, and it was identified that the cuff of the device was punctured, causing the problem reported above.A foley probe was provisionally passed.

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 supplier corrective action has already been opened to address the reported condition through a more robust investigation.In the meantime, all information received will be used for further tracking and trending purposes.

• 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: 18503243
• MDR Text Key: 332782362
• Report Number: 9612030-2024-00017
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 1927420164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2024
• Date Device Manufactured: 10/19/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1