MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 20FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884720205

Device Problem Unintended Deflation (4061)

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

Event Type  malfunction  

Event Description

The customer reported that the balloon broke.Per additional information received on 6-jul-2022, it was a hole that caused the balloon to deflate.This occurred during the pre-test.There were no fragmented parts.There was no injury/damage to the patient.No medical intervention or treatment was required.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) was reviewed, and no discrepancy was found relating to the reported issue.Abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.A sample analysis could not be completed because there were no samples or digital image submitted with this complaint.This complaint will be reopened and updated if a sample is received at a later date.Based on the available information, a root cause could not be determined.The current process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.However as containment, a notification was made to the production personnel so that they are aware of the condition reported.No corrective and preventative action is required at this time.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

One gastro feed tube with y-port 20fr with unknown lot number was received for evaluation.This is a component from an external supplier.A complaint notification was sent to the supplier to initiate the investigation.Per the supplier, the balloon end of the returned device was damaged beyond repair from a burst, cut or tear.Further inspection was conducted using a microscope and lighted magnifying glass.The inspection was for additional issues such as voids, nicks, manufacturing defects, or anything else that may induce device failure.The inspection resulted in no additional observations.The affected device is a used device and not considered an out of box failure.The unit has minor debris in the feeding lumen and apparent wear was observed.Because the device is used, it¿s subject to other factors that can contribute to device failure such as, age of the device, patient conditions, under or over inflation of the balloon lumen, misuse, environment, mishandling, drop, instructions for use not being followed, etc.With the minimal information provided and because the device was used, the root cause cannot be definitively confirmed.Current controls are in place which include training and certification of all production personnel and qc inspectors.Line clearances are performed and documented at each workstation.All molds, presses, and testing equipment used to manufacture the product line are documented within device history records and cleaned and calibrated when applicable.Controls surrounding the actual silicone material used include stringent storage, milling, cleaning, and extrusion rules.Detailed dhr/pic (pictorial instructions) are present at each workstation and deliver specific guidance for every step of the manufacturing process.To mitigate the risk of releasing devices with balloon failures, each unit is 100% tested during the process, where it is inflated for a minimum of 10 minutes and inspected visually prior to accepting the unit for distribution.Additionally, qc inspects at an aql level to verify the integrity of the balloon.The production floor contains pictures, reminders, and icons of no sharp objects (razors) are acceptable around workstations where the cuff bonding or testing occurs.With all the controls in place through the manufacturing process, this limits the risk of releasing nonconforming products.No corrective actions are warranted at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 20FR
• 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: 14929865
• MDR Text Key: 303733702
• Report Number: 9612030-2022-03307
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521007291
• UDI-Public: 10884521007291
• 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,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720205
• Device Catalogue Number: 8884720205
• Device Lot Number: 2112448664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1