MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 22FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720221
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that at the time of testing the gastro tube, it was perforated.
Additional Manufacturer Narrative
The device history record was reviewed, the device was manufactured on december 05, 2020 and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue reported.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Samples were not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported condition or 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.We will continue to monitor the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Upon submission of the initial report (report number 9612030-2021-03085), the clinical, impact, and medical device problem codes were inadvertently left blank.Section h6 has been updated to reflect all three codes of 4582, 2199, and 2205.

• Brand Name: GSTRO FEED TBE W/Y PRT 22FR
• 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: 12800123
• Report Number: 9612030-2021-03085
• Device Sequence Number: 5271057
• Product Code: KNT
• UDI-Device Identifier: 10884521007321
• UDI-Public: 10884521007321
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 8884720221
• Device Catalogue Number: 8884720221
• Device Lot Number: 2032944664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 11/17/2021
• Date Device Manufactured: 12/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male