MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 18FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720189
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported there was a hole in the balloon.During use they realized the balloon was emptying.The feeding tube was replaced and the second feeding tube also had a hole in the balloon and was replaced.There was no injury to the patient.
Additional Manufacturer Narrative
Additional information: h4 manufacture date was added.The device history record (dhr) review was performed showing no discrepancy was found according to the failure mode reported.A sample analysis could not be performed because no photo or sample was available for evaluation.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.A root cause could not be determined with the available information.The manufacturing process was reviewed.Process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.The current process is running according to product specifications meeting quality acceptance criteria.As part of the containment, a notification was made to the production personnel of the line so that they are aware of the condition reported by the client.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 18FR
• 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: 15293183
• Report Number: 9612030-2022-03364
• Device Sequence Number: 7054572
• Product Code: KNT
• UDI-Device Identifier: 10884521007284
• UDI-Public: 10884521007284
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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: 8884720189
• Device Catalogue Number: 8884720189
• Device Lot Number: 2106834864
• 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: 08/17/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/29/2022
• Date Device Manufactured: 03/19/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown