MAUDE Adverse Event Report: COVIDIEN LP KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721088
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
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 displaced tungsten nutrition probe was assessed by head and neck cx nidya consuelo guataquira sierra, specialist in head and neck surgery.Head and neck surgery's analysis: presented dislodgement of tungsten probe and rupture of the same for which it was replaced without complication.A control x-ray was requested at 13:37pm for which it was considered an adverse event related to medical supplies tungsten probe, which apparently broke, generating a new intervention in the patient.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no photos or physical samples received for investigation.Based on all available information, we were unable to confirm the reported condition or determine the root cause.If a sample is received at a later date, the investigation will be updated accordingly.Staff has been notified of the reported condition to raise awareness.This complaint will be used for tracking and trending purposes.Device manufacture date: 06-dec-2022.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN LP; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20515874
• Report Number: 1423537-2024-00257
• Device Sequence Number: 7203935
• Product Code: KNT
• UDI-Device Identifier: 10884521518872
• UDI-Public: (01)10884521518872(17)271031(10)2233331264
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K833621
• 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): 11/13/2024

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: 8884721088
• Device Catalogue Number: 8884721088
• Device Lot Number: 2233331264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female