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)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the tips have broken off of the feeding tubes (item code 8884741821) in the kits.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 reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits.A gemba walk was performed, and the manufacturing process was reviewed.All process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections performed to the product.In addition, qc inspections are performed to the product for material release; and production personnel performs a 100% visual inspection during the packaging process, in order to detect and discard any identified issues.There were four photos and three physical samples received for investigation.The samples arrived without the original packaging.The samples were inspected, and the reported condition was confirmed in one of the samples, the adapter was detached from the tube.Based on all available information, a definitive root cause could not be determined at this time and the reported condition is considered to be an isolated event.Production personnel has received an alert notification to heighten awareness of the reported condition.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: 14225129
• Report Number: 9612030-2022-03234
• Device Sequence Number: 4193879
• 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): 08/30/2022

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 Expiration Date: 11/01/2022
• Device Model Number: 8884742019
• Device Catalogue Number: 8884742019
• Device Lot Number: 1729687164
• 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: 04/27/2022
• Supplement Report FDA Received Date: 08/30/2022
• 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