MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR 43IN W STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721088E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the ng tube was found to be broken above the metal weights.All of the metal pieces appear to remain intact and contained within the tubing, but the tubing remained connected by only approximately 4mm.The tubing became completely separated after being placed into plastic bag for assessment.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on (b)(6) 2024.A physical sample was not received for investigation, but a photo provided.The photo was evaluated and confirmed the rupture of the tube near the tip of the bolus.Based on all available information, a definitive root cause could not be determined at this time.If the device is received at a later date, the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.We will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Correction made to section d3.

• Brand Name: ENTRFLX 10FR 43IN W STY YPORT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19805156
• Report Number: 1423537-2024-00081
• Device Sequence Number: 8348837
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• 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,Followup
• Report Date (Section B): 07/25/2024

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: 8884721088E
• Device Catalogue Number: 8884721088E
• Device Lot Number: 2405901764
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 07/23/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown