MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 16FR X 1.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	716150
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the balloon did not inflate.No injuries occurred.Per additional information provided on 08-feb-2022, the issue occurred during patient use.There were holes/cracks observed in the balloon.The problem was resolved by removing and replacing the device.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed, 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.The device was manufactured on january 13, 2021.There were no physical samples, digital images, or videos received for evaluation.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 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, complaints, and feedback for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 16FR X 1.5CM
• 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: 13502029
• Report Number: 9612030-2022-03163
• Device Sequence Number: 3953084
• Product Code: KNT
• UDI-Device Identifier: 10884521010987
• UDI-Public: 10884521010987
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: 716150
• Device Catalogue Number: 716150
• Device Lot Number: 2100532364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown