MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 20FR X 2.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 720250

Device Problem Unintended Deflation (4061)

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

Event Date 03/24/2022

Event Type  malfunction  

Event Description

The customer reported that during a visit carried out, it was observed that the button was loose.A cuff test was performed and it was observed that the cuff did not inflate and air came out on the side.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The device was manufactured on july 24, 2019.There were no physical samples or digital images received for evaluation.As a result, sample analysis could not be performed confirm the reported issue and determine the root cause.However, a supplier corrective action report has been forwarded to the supplier.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

One decontaminated sample was received at the manufacturing site for investigation.The sample was visually and functionally tested, and the reported condition was confirmed; the balloon was inflated with water and a pin hole/leak was detected in the lower part of the tube.The affected component is produced by an external supplier; our assembly process consists only of a pick and place operation for this material.A supplier corrective action report has been forwarded to the supplier.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 20FR X 2.5CM
• 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: 14022153
• MDR Text Key: 288806463
• Report Number: 9612030-2022-03207
• Device Sequence Number: 1
• Product Code: KNT
• 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,Followup
• Report Date: 05/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 720250
• Device Catalogue Number: 720250
• Device Lot Number: 1919725564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 04/05/2022; Not provided
• Supplement Dates FDA Received: 05/07/2022; 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 98 YR
• Patient Sex: Male