MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 18FR X 2.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 718200

Device Problem Unintended Deflation (4061)

Patient Problem Burn(s) (1757)

Event Date 04/25/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the balloon was placed (b)(6) 2023 and it failed for leaking on (b)(6) 2023.This resulted in burnt skin from gastric acid.A new balloon was placed on (b)(6) 2023.No further information has been provided.

Manufacturer Narrative

One sample was received for evaluation.A visual inspection and a functional test was performed per procedure.It was observed that the union part between the valve and the balloon tube was broken, which caused a leak.A corrective and preventive action has been initiated to further address this issue.

Event Description

The customer reported that the balloon was placed (b)(6) 2023 and it failed for leaking on (b)(6) 2023.This resulted in burnt skin from gastric acid.A new balloon was placed on 26apr2023.Additional information received on 27apr2023 stated that the peg dietitian used topical ointment for treatment (sudocream) to relieve redness and itching.

Manufacturer Narrative

Sections b5 and h6 health effect - impact code were updated due to additional information received.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample has not yet been received for the investigation and we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.However, a corrective and preventive action has been initiated to further address the reported issue.

• Brand Name: BALLOON SLG 18FR X 2.0CM
• Type of Device: 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: 16820479
• MDR Text Key: 314086048
• Report Number: 9612030-2023-03685
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 718200
• Device Catalogue Number: 718200
• Device Lot Number: 2213020664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Sex: Female