MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 14FR; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884715148

Device Problem Material Rupture (1546)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation because it was discarded.

Event Description

Customer reports: the patient has a kangaroo gastrostomy tube with y port.As per manufacturer's instructions, the g-tube balloon is deflated and re-inflated.However, the daily deflating and re-inflating, weakened the retention balloon and the patient experienced a rupturing of the retention balloon while the tube was in use.Staff noticed this after some time as the gastric tube was sliding out.Also, there was some friction related redness at the insertion site as the tube was able to slide in and out during use.It is unclear why the manufacturer's instruction's require daily vs weekly deflating and reflating of the gastric tube balloon.Unfortunately, the faulty g-tube was thrown out by staff during the exchange process, thus a lot number cannot be provided.The tube was also initially inserted in community (ltc).This is also not the first time that we have experienced this at the bedside.Unfortunately, with previous g-tube balloon rupture, staff did not report to this.There was redness at the insertion site indicative of friction irritation due to retention balloon failure.

Manufacturer Narrative

The device history record review could not be performed since no lot number was provided from customer complaint report, and no photo sample/actual sample with a lot number was received.The physical sample was not returned; however, two images were submitted for reference.After performing a visual inspection, the sample analysis was performed on the photograph.Based on this analysis, the condition reported by customer was not observed in the images because it is necessary to see how the product works in order to make a determination, therefore the condition reported could not be confirmed.A gemba walk was done at the manufacturing facility focusing on the manufacturing equipment and process; a current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections; however, there have been similar cases reported in the past, of which a formal corrective/preventative action (capa) was issued to the supplier to address the root cause and action plan.

• Brand Name: GSTRO FEED TBE W/Y PRT 14FR
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 18005801
• MDR Text Key: 326527841
• Report Number: 9612030-2023-03843
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521007222
• UDI-Public: 10884521007222
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884715148
• Device Catalogue Number: 8884715148
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2023
• 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