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	Burn(s) (1757)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tip of the extension cracks off inside the gtube opening.Because the small plastic piece breaks off inside the gtube, this leaves the gtube open causing stomach contents leak.The plastic piece stuck in the gtube leaves the valve open spewing stomach contents all over her stomach causing acid burns which took over a week to heal.Per additional information received on (b)(6) 2022, the customer went to the er to have the piece removed from inside the gtube itself.There was no medication needed at the er but the customer used steroid cream from an old doctors prescription for the burns on their stomach.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Two photo samples were received for evaluation.Based solely on the photo sample, the reported condition could not be confirmed.Subsequently, three representative samples without original packaging were received at the manufacturing site.The samples were visually inspected, and one was detached from adapter to the tube.The other two samples were not detached.The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A possible root cause of this condition would be a lack of solvent during the assembly process.This incident is considered an isolated event.As a corrective action, production personnel received an alert notification to heighten awareness of the reported condition.

• Brand Name: SKN LVL GASTRO TB 20FR 1.5CM
• 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: 14526694
• Report Number: 9612030-2022-03265
• Device Sequence Number: 20292838
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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: 05/11/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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