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

Model Number 714150

Device Problem Break (1069)

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

Event Date 11/20/2022

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Event Description

The customer reported a broken balloon.No injuries were reported.

Manufacturer Narrative

One physical sample was received at the manufacturing site for investigation.The sample was visually and functionally inspected, and the reported condition was confirmed.The affected component is produced by an external supplier.A supplier corrective action request (scar) has been issued to the supplier to further investigate and address the reported condition.This complaint 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 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: 15953307
• MDR Text Key: 307932424
• Report Number: 9612030-2022-03490
• 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
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 714150
• Device Catalogue Number: 714150
• Device Lot Number: 2125709164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1