MAUDE Adverse Event Report: CARDINAL HEALTH SKN LVL GASTRO TB 20FR 1.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884742019
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the tip has broken off of the feeding tube (item code 8884741821) in the kit.No injuries have occurred.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue reported.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The kit was manufactured on october 31, 2017.A physical sample was not received for the investigation, but four photos were provided.The photos were evaluated but it was not possible to confirm the reported issue through the photos.A physical sample is required for further investigation.Without a physical sample we are unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: SKN LVL GASTRO TB 20FR 1.5CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 14413124
• Report Number: 9612030-2022-03250
• Device Sequence Number: 12125479
• Product Code: KNT
• UDI-Device Identifier: 10884521011663
• UDI-Public: 10884521011663
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: 8884742019
• Device Catalogue Number: 8884742019
• Device Lot Number: 1729687164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown