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

Model Number	724350
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2022-03174
• Device Sequence Number: 17575554
• Product Code: KNT
• UDI-Device Identifier: 10884521011465
• UDI-Public: 10884521011465
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown