MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 12 FR X 0.80 CM; PUMP, INFUSION, ENTERAL

Model Number	712080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The client reports that he has purchased the product for a 3 year old patient, and knows the care and specifications, but he has had a perforation.When reviewing it, it turned out to have burst the fixation balloon.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for the affected lot was review, showed that manufacturing and inspection product was performed as per applicable procedures and validated process.All inspection results were carried out and were within acceptable criteria as per established sampling plan levels quality procedures.A sample was not returned for evaluation, consequently, it was not possible to evaluate it as part of a comprehensive failure investigation.The root cause and corrective actions could not be identified without a sample to evaluate.The affected component is produced by an external supplier; our assembly process only consists in a pick and place operation for this material.A formal corrective/preventative action (capa) has been opened to further investigate the reported issue.

• Brand Name: BALLOON SLG 12 FR X 0.80 CM
• Common Device Name: PUMP, INFUSION, ENTERAL
• 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: 16668563
• Report Number: 9612030-2023-03665
• Device Sequence Number: 15104862
• Product Code: LZH
• UDI-Device Identifier: 10884521010475
• UDI-Public: 10884521010475
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 06/02/2023

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: 712080
• Device Catalogue Number: 712080
• Device Lot Number: 1828112864
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 06/02/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown