MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 16FR X 1.7CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 716170

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problems Failure to Anastomose (1028); Pain (1994)

Event Date 03/14/2023

Event Type  malfunction  

Event Description

Customer reports: the shaft of the skin level device (sld) was broken, just prior to the time that it was due for a regular change.The patient went to the emergency department in pain with a leaking stoma for a day.The sld was found to be leaking.The patient was referred to the percutaneous endoscopic gastrostomy (peg) clinic in 4 days time with skin burns around the sld dressings.

Manufacturer Narrative

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

Manufacturer Narrative

Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: BALLOON SLG 16FR X 1.7CM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02748
• 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: 17970215
• MDR Text Key: 326272690
• Report Number: 9612030-2023-03840
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521010994
• UDI-Public: 10884521010994
• 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
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 716170
• Device Catalogue Number: 716170
• Device Lot Number: 2113126564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1