MAUDE Adverse Event Report: CARDINAL HEALTH POLYUR FEED TUBE 3.5 FR X 12; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 461355

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the hub of feeding tube fell off while it was still placed in the patient and bedside nurse quickly removed the product and kept as sample.Additional information was received and stated that the whole purple part was disconnected, and the device was removed; however, it was unknown if the device was replaced.Per customer, the patient harm information is unknown at this time.

Manufacturer Narrative

The device history record review could not be performed since no lot number was provided from customer complaint report.One sample with unknown lot number was received for evaluation.After performing a visual inspection, the separation of the purple connector was observed.A gemba walk was carried out with the multifunctional team on the production line.It was determined that the detachment of the purple connector was due to the lack of solvent.An improvement opportunity was detected to update the standard work instruction to prevent the reoccurrence of the reported condition.No further actions are required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: POLYUR FEED TUBE 3.5 FR X 12
• 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: 15983648
• MDR Text Key: 307112798
• Report Number: 9612030-2022-03493
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 20884521067391
• UDI-Public: 10884521067394
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

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: 461355
• Device Catalogue Number: 461355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1