MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14FR X 1.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 714150

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

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.

Event Description

Customer reports: the balloon burst on the sld.

Manufacturer Narrative

Based on the information available to us, we were able to confirm the event.The device history record review could not be performed since no lot number was provided from customer complaint report, and no photo/actual sample with a lot number was received; not a valid lot number.One decontaminated sample was received for evaluation.A visual inspection was performed according to procedure.Additionally, a functional test was performed; it was observed that it was leaking in the tip of the tube.The root cause and action plan will be documented through a formal corrective/preventative action which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 14FR X 1.5CM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; mansfield MA
• 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: 18123801
• MDR Text Key: 328034946
• Report Number: 9612030-2023-03855
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521010642
• UDI-Public: 10884521010642
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 714150
• Device Catalogue Number: 714150
• 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