MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 12FR 43IN W STYL YPOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721252E

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 they have experienced quality issues with the product, as the product broke.Additional information was received and stated that the purple tip where the syringe screws in, broke off.This has happened twice.The patient was very difficult to place and had to go to radiology twice to get it replaced causing extra exposure to radiation.The customer further stated that this has happened with the same patient on night shift but by two different staff members.The patient had nasogastric (ng) tube placed by radiology.Per customer, first one broke during night shift, patient went back to radiology to have another one replaced.The second one broke on night shift on (b)(6)2023.The patient went to radiology for 3rd time to have another one placed and no more have broken since.

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 09-nov-2022.A picture of the catalog was provided for analysis.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: ENTRFLX 12FR 43IN W STYL YPOR
• 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: 17090645
• MDR Text Key: 317529961
• Report Number: 9612030-2023-03720
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• 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: 08/01/2023

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: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2230601964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1