MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 16FR EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884720163E

Device Problem Unintended Deflation (4061)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

The customer reported that a registered nurse (rn) was helping a patient with gastrostomy tube (g tube).The bedside nurse indicated that the dayshift staff stated that g tube seemed not to be anchored well/properly.They attempted to remove the tape from dressing and noticed that the g tube seemed to almost dislodge from the hole completely.Dressing was re-applied, and advanced practice nurse (apn) was notified.The apn at bedside noticed that the balloon port was malfunctioned or not full to properly anchor the g tube securely.The apn pulled back on balloon port and a milky white substance was noted indicating that the balloon likely was not intact.Therefore, the g tube was removed and found that the balloon was indeed not intact.New g tube was placed per apn and peds surgery notified by apn.There was no patient harm reported.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record review could not be performed since no lot number was provided.The device was received for evaluation and the reported condition has been confirmed.A supplier corrective action request has been opened to address the reported condition.

• Brand Name: GSTRO FEED TBE W/Y PRT 16FR EN
• 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: 18479947
• MDR Text Key: 332495946
• Report Number: 9612030-2024-00007
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884720163E
• Device Catalogue Number: 8884720163E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1