MAUDE Adverse Event Report: CARDINAL HEALTH 12 FR X 55 ENTRIFLEX W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721255

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The cardinal health warehouse has noticed that the product was aging and has turned yellow, and the weighted tip was detached.The product was not used.

Manufacturer Narrative

Based on the information available to us, 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.Eight pictures and six samples were received for analysis.The six samples were visually inspected, and the returned samples met the color specification.Therefore, the reported issue of product turned yellow is not confirmed.Out of 6 received samples, one sample had detachment between the tube to the connector and the second sample had recoil between the tube and the connector.Therefore, the reported issue of disassembled tip issue was confirmed.The other four sample did not have disassembly issue.A corrective and preventive action has been initiated to address the disassembled tip issue.

• Brand Name: 12 FR X 55 ENTRIFLEX W/STYLET
• 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
• MDR Report Key: 16820258
• MDR Text Key: 314086103
• Report Number: 9612030-2023-03684
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518926
• UDI-Public: 10884521518926
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

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 Model Number: 8884721255
• Device Catalogue Number: 8884721255
• Device Lot Number: 2019611464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1