MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 24FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720247
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: on 03/02/2023, the doctor performed an exchange, placing the kangaroo brand probe.On (b)(6) 2023, it was observed that a replacement was required as the balloon had ruptured.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluation comment - the customer stated that the device will not be returned for evaluation because it had been discarded.
Additional Manufacturer Narrative
The device history record (dhr) for the reports lots were reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.A sample analysis was not possible as there was no photographs or samples provided for evaluation.Without a sample to evaluate, it is not possible to confirm the reported issue, determine a root cause or relate it to a manufacturing process.All associated lot documentation was carefully reviewed; no issues or discrepancies were found related to the reported complaint.This complaint will be closed with no further action; if sample is received later, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 24FR
• Common Device Name: 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: 16575779
• Report Number: 9612030-2023-03646
• Device Sequence Number: 7150281
• Product Code: KNT
• UDI-Device Identifier: 10884521007352
• UDI-Public: 10884521007352
• 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,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: 8884720247
• Device Catalogue Number: 8884720247
• Device Lot Number: 2203404064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown