MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14FR X 1.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 714100

Device Problem Unintended Deflation (4061)

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

Event Date 01/28/2022

Event Type  malfunction  

Event Description

The customer reported that the probe had a hole in the balloon on the first day of use.Per additional information received on 11mar2022, there was no medical intervention required.They were not informed if the device was replaced.

Manufacturer Narrative

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

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, 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.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 14FR X 1.0CM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 13977942
• MDR Text Key: 292197851
• Report Number: 9612030-2022-03198
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521010628
• UDI-Public: 10884521010628
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 714100
• Device Catalogue Number: 714100
• Device Lot Number: 1920000464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2022
• Date Device Manufactured: 07/22/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1