MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 18FR X 1.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	718150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: an 18fr 1.5cm nutriport was placed (b)(6) 2023, in a 2 year old patient.The balloon burst on (b)(6) 2023, and was replaced.
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.According due to similar cases presented in the past, a formal corrective/preventative action (capa) has been opened to document the reported issue.
Event or Problem Description
Additional information received on 04/26/23 states that the balloon was inflated with 6ml of sterile water.The balloon burst whilst inside the patient¿s gut.It is assumed that the fragments were passed by patient.There was no further medical intervention.
Additional Manufacturer Narrative
Additional updates to the 3500a: section b5: describe event or problem - additional information received on 04/26/23 added.Section h6: health effect - additional information received on 04/26/23 therefore the clinical code 2687 was added.

• Brand Name: BALLOON SLG 18FR X 1.5CM
• 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: 16797311
• Report Number: 9612030-2023-03682
• Device Sequence Number: 16956731
• Product Code: KNT
• UDI-Device Identifier: 10884521011120
• UDI-Public: 10884521011120
• 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): 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: 718150
• Device Catalogue Number: 718150
• Device Lot Number: 2113126564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 04/24/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 05/03/2023; 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 Age: 2 YR
• Patient Sex: Unknown