MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 18 FR X 2.7 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	718270
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
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 clinician replaced a nutriport in a young boy today after the balloon burst at school this morning.The burst balloon had been placed on (b)(6) 2022 and popped today therefore only just over a month old.No injury reported.
Additional Manufacturer Narrative
The device history record was reviewed.No abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Sample analysis could not be performed since no photos or physical samples were provided for evaluation.The complaint shall be reopened if a sample is received at a later date.A notification was forwarded the supplier of the reported component to confirm the root cause and determine if a corrective and preventive action is needed.This complaint will be used for tracing and trending purposes.

• Brand Name: BALLOON SLG 18 FR X 2.7 CM
• 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: 15104914
• Report Number: 9612030-2022-03333
• Device Sequence Number: 12065469
• Product Code: KNT
• UDI-Device Identifier: 10884521011175
• UDI-Public: 10884521011175
• 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
• Report Date (Section B): 08/23/2022

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: 718270
• Device Catalogue Number: 718270
• Device Lot Number: 2111030864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/23/2022
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown