MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 24FR X 1.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	724150
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	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: a 24cm 1.5cm nutriport was placed on (b)(6) 2023.The balloon burst on (b)(6) 2023.A replacement for the device was a 24fr 1.7cm product code# 724170, lot# 1933033964 as there was no supply available in the region for the initial sizing (24cm 1.5cm).
Additional Manufacturer Narrative
Additional updates to the 3500a: section b5: describe event or problem - additional information received on 04/266/23 added.Section h6: health effect - additional information received on 04/27/23 therefore the clinical code 2687 was added.
Event or Problem Description
Additional information received on 04/27/23 states that the balloon was inflated with 6ml of sterile water.The balloon burst whilst in situ therefore the fragments will have been passed by patient.There was no further medical intervention.

• Brand Name: BALLOON SLG 24FR 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: 16798449
• Report Number: 9612030-2023-03683
• Device Sequence Number: 16928742
• Product Code: KNT
• UDI-Device Identifier: 10884521011397
• UDI-Public: 10884521011397
• 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): 05/03/2023

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: 724150
• Device Catalogue Number: 724150
• Device Lot Number: 2027312064
• 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
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 05/03/2023
• 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