MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR 43IN W STY YPORT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884721088

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The customer reported that after passing the probe in the patient, in an attempt to remove the manor, it broke, and it was not possible to remove.The professional had to remove the probe and perform a new passage with a probe from another manufacturer.Per customer, the patient had undergone neurological surgery and had more strict care regarding procedures.There was no patient harm reported.From the picture provided by the customer, the green cap detached from the guide.

Manufacturer Narrative

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

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 17-aug-2020.No physical sample was received for the evaluation; however, a picture was provided for the analysis.Upon reviewing the picture, detached green cap can be observed.The reported issue is confirmed.The investigation was carried out with the multifunctional team, current processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.A probable cause that could have caused this issue could be due to inappropriate method of use in according to instruction for use (ifu).Placement confirmation must be determined by x-ray.Supportive confirmation includes auscultation of the upper left quadrant during injection of air using a syringe and aspiration of gastric contents.Placement confirmation should be confirmed with a stylet secured within the tube.Once the tube position has been confirmed, reactivate the hydromer coating with another 10 ml of water before attempting removal if the stylet has been indwelling for any appreciable time.The stylet is then removed by gentle traction (if stylet is used).Tape the tube securely, avoiding pressure on the nares.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: ENTRFLX 10FR 43IN W STY YPORT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 14743459
• MDR Text Key: 301850800
• Report Number: 9612030-2022-03288
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• 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: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884721088
• Device Catalogue Number: 8884721088
• Device Lot Number: 2022315464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1