MAUDE Adverse Event Report: CARDINAL HEALTH PVC FEEDING TUBE 3.5 FR 12; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461206
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	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: the green cap disconnected from the feeding tube, leaving only the small tubing in the baby hanging out.This poses a risk of infection and aspiration.Per additional information received on 11/08/22, there was no harm.The device was replaced and the patient was discharged home.
Additional Manufacturer Narrative
The device history record file was reviewed, and no discrepancy was found according to the failure mode reported.One sample with an unknown lot number was received for evaluation.After performing visual inspection based on product specification, the detachment of the purple connector can be observed.A gemba walk through was performed in the manufacturing area with a multifunctional team (quality, manufacturing, engineering); after the gemba walk, the specific root cause could not be found.The current process was running according to approved specifications.A definitive root cause could not be determined.This is the first complaint related to this incident during the past year; there isn't a negative trend that indicates a potential issue on the process.This incident can be considered an isolated event.Controls in the standard work instruction in which a tension test is performed to confirm the connector is not detached prior to release of the product.Production personnel was provided an awareness notification of reported condition.

• Brand Name: PVC FEEDING TUBE 3.5 FR 12
• 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: 15754230
• Report Number: 9612030-2022-03457
• Device Sequence Number: 12341479
• Product Code: KNT
• UDI-Device Identifier: 10884521067387
• UDI-Public: 10884521067387
• 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): 01/12/2023

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: 461206
• Device Catalogue Number: 461206
• Device Lot Number: 2222407064
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown