MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 18FR X 2.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	718250
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
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 a split balloon, balloon failed.No patient injury was reported.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated nutriport without its original packaging with lot 1933729064 was received for evaluation.The visual inspection was performed according to the procedure along with a functional test.A leak was observed in the balloon.The reported issue was confirmed.The affected device is provided by an external supplier.A supplier corrective action report (scar) was generated and submitted to the supplier.The root cause and any corrective actions, if applicable, will be addressed by the supplier.Cardinal health will continue monitoring the process, customer complaints and feedback notifications for any adverse trends that require immediate attention.

• Brand Name: BALLOON SLG 18FR X 2.5CM
• 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: 13446455
• Report Number: 9612030-2022-03156
• Device Sequence Number: 17223835
• Product Code: KNT
• UDI-Device Identifier: 10884521011168
• UDI-Public: 10884521011168
• 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): 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: 718250
• Device Catalogue Number: 718250
• Device Lot Number: 1933729064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown