MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 24FR X 3.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 724350

Device Problem Unintended Deflation (4061)

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

Event Date 01/22/2022

Event Type  malfunction  

Event Description

The customer reported that after two days of using the probe, it dislodged because the balloon was not holding inflation.Per additional information received, the doctor had to go to the patient's home to perform the replacement.The device was replaced by another nutriport tube.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

The customer reported that after two days of using the probe, it dislodged because the balloon was not holding inflation.Per additional information received, the doctor had to go to the patient's home to perform the replacement.The device was replaced by another nutriport tube.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The device was manufactured on 05-feb-2020.One used sample was received for the analysis.Visual inspection was performed, in addition a functional test was performed.The balloon was inflated with water and left for a few minutes; no leak was observed in the device.Therefore, the reported condition is not confirmed; however, as a part of continuous improvements, a corrective action (capa) has been opened to address the reported issue through a more robust investigation.The results of investigation will be documented through the referred capa.

• Brand Name: BALLOON SLG 24FR X 3.5CM
• 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: 13585746
• MDR Text Key: 286012542
• Report Number: 9612030-2022-03174
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521011465
• UDI-Public: 10884521011465
• 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: 05/02/2022

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: 724350
• Device Catalogue Number: 724350
• Device Lot Number: 2002820664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1