MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 12FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884715122

Device Problem Unintended Deflation (4061)

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

Event Date 12/24/2021

Event Type  Injury  

Event Description

The customer reported that on (b)(6) 2021 a (b)(6) old patient on postoperative day two of laparoscopic gastrostomy was using kangaroo gastrostomy tube with balloon # 12.The patient started enteral nutrition and the assistant was monitoring evidence of the full sheet of gastric content.The chief in charge of nutritional support was notified and she verified and tested by pouring water with a syringe into the tube, capping it and then turning it over and there was water leakage.It was also evidenced on (b)(6) 2021 that there was displacement of the probe, which moved to the abdominal wall.In the morning, the head in charge of the patient evidenced the probe outside.The balloon was left outside and lost water because the surgeon filled it with 3cc of water and he woke up with 2cc, losing 1cc of water in just four days.The patient was transferred back to surgery to properly reposition the catheter.Per additional information received on 01/14/2022, the customer stated there was leaking from the y port.In addition to the leaking y port, the balloon deflated causing the tube to be displaced from the patient and then a new tube was replaced.Per the customer, the balloon volume was checked daily, however they did not have record of how much volume the balloon had on each day.The customer stated that the patient was transported back to surgery for replacement, however it was not reported what type of procedure was performed.The customer stated they did not notice any holes and/or cuts on the balloon itself.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) file was reviewed, and no discrepancy was found related to the reported condition.Two digital images, and one video was provided for evaluation.A sample analysis was completed using the images and the video provided by the customer.The balloon leak is not observed in the images and video however the y-port leak is observed.However, the physical sample is required to perform a functional test of the device to confirm the reported condition.Without the product sample to evaluate, a root cause could not be identified, and corrective actions implemented.The current process is running according to product specifications meeting quality acceptance criteria.A production notification was issued to all personnel to heighten awareness of the condition reported by the customer.

• Brand Name: GSTRO FEED TBE W/Y PRT 12FR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 13308087
• MDR Text Key: 284126699
• Report Number: 9612030-2022-03141
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521007154
• UDI-Public: 10884521007154
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884715122
• Device Catalogue Number: 8884715122
• Device Lot Number: 2106834664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 12/24/2021
• Supplement Dates FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 MO