MAUDE Adverse Event Report: CARDINAL HEALTH, INC. COVIDIEN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720205E
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
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 balloon of the tube ruptured 4 weeks after placement.Per additional information received, the tube had to be replaced.
Additional Manufacturer Narrative
Updated section g3 / g4 date received by manufacturer from "10-jun-2023" to "10-jun-2024".
Additional Manufacturer Narrative
Pma/510(k)number to k180622.Device manufacturer date to 14-dec-2022.Labeled for single use? to yes.A photo sample was received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the photo sample, the reported was confirmed; a ruptured balloon was confirmed.The root cause and action plan will be documented through a formal corrective/preventative action which has been initiated to address the reported condition to mitigate any further occurrences.Corrected: brand name from: gstro feed tbe w/y prt 24fr to: covidien.Manufacturer name to from: cardinal health to: cardinal health, inc.Model number/catalog number from: 8884720247 to: 8884720205e.Unique identifier (udi) # (b)(4).

• Brand Name: COVIDIEN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 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: 19817497
• Report Number: 1423537-2024-00064
• Device Sequence Number: 12927971
• Product Code: KNT
• UDI-Device Identifier: 10884521661714
• UDI-Public: (01)10884521661714(17)270301(10)2324408164
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K180622
• 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,Followup
• Report Date (Section B): 08/09/2024

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: 8884720205E
• Device Catalogue Number: 8884720205E
• Device Lot Number: 2324408164
• 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: 06/10/2023
• Supplement Date Received by Manufacturer: 06/10/2024; Not provided
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/05/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown