MAUDE Adverse Event Report: CARDINAL HEALTH PEDI-TUBE 6FR 36 NON-WGT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884730790

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

The customer reported the tube was packaged in a way that it was bent oddly and making it difficult to install.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) was reviewed showing manufacturing and inspection of the product was performed as per applicable procedures and validated process.All processes and controls were found to be followed correctly.Two pictures and one sample were received for evaluation.The sample was visually checked, and it was observed that the tube was distorted.The reported condition was confirmed.A root cause could not be determined.No action plan is required at this point.As awareness, production personnel received retraining regarding the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: PEDI-TUBE 6FR 36 NON-WGT
• 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: 17396689
• MDR Text Key: 319772109
• Report Number: 9612030-2023-03773
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 40884521009654
• UDI-Public: 40884521009654
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884730790
• Device Catalogue Number: 8884730790
• Device Lot Number: 2222134464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1