MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14 FR X 1.2 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	714120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
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 device split where there shaft meets the top of the button causing large leakage and irritation.The device was placed on (b)(6) 2021 and removed on (b)(6) 2021, it had started leaking the week prior.
Additional Manufacturer Narrative
One decontaminated nutriport without its original packaging with lot 1812883764 was received for evaluation.The visual inspection was performed according to the procedure.It could be observed that there is a crack in the upper part of the tube, which confirms the condition reported.The affected device is supplied by an external vendor.A supplier corrective action report (scar) was generated and submitted to the vendor.The root cause and any corrective actions, if applicable, will be addressed by the vendor.Cardinal health will continue monitoring the process, customer complaints and feedback notifications for any adverse trends that require immediate attention.
Additional Manufacturer Narrative
Updated section b5 describe event or problem to fix an incorrect word.Investigation results: no samples or photos were received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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 issue and determine a root cause.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.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported that the device split where the shaft meets the top of the button causing large leakage and irritation.The device was placed on (b)(6) 2021 and removed on (b)(6) 2021, it had started leaking the week prior.

• Brand Name: BALLOON SLG 14 FR X 1.2 CM
• 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: 12988420
• Report Number: 9612030-2021-03121
• Device Sequence Number: 17461605
• Product Code: KNT
• UDI-Device Identifier: 10884521010635
• UDI-Public: 10884521010635
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/15/2022

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: 714120
• Device Catalogue Number: 714120
• Device Lot Number: 1812883764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 11/25/2021; 11/25/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/24/2022; 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown