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

Model Number	8884730790
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the tube was packaged in a way that it was bent oddly and making it difficult to install.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2023-03773
• Device Sequence Number: 12275605
• Product Code: KNT
• UDI-Device Identifier: 40884521009654
• UDI-Public: 40884521009654
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: 8884730790
• Device Catalogue Number: 8884730790
• Device Lot Number: 2222134464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown