MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 20FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884720205

Device Problem Deflation Problem (1149)

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

Event Date 06/10/2022

Event Type  malfunction  

Event Description

The customer reported the feeding tube had a pin hole in the balloon.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) review showed no discrepancy related to the reported failure.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.Based on the present information it was not possible to determine an exact root cause.The current 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.A risk assessment was performed to determine the occurrence of the reported failure mode.No action plan is deemed required.The current process is running according to product specifications, meeting quality acceptance criteria.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.As part of the containment, a notification was made to the production personnel of the bulk line as awareness notification of the condition reported by the customer.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 20FR
• Type of Device: 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: 14711795
• MDR Text Key: 301263591
• Report Number: 9612030-2022-03282
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521007291
• UDI-Public: 10884521007291
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

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: 8884720205
• Device Catalogue Number: 8884720205
• Device Lot Number: 2129332264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 07/14/2022
• Date Device Manufactured: 10/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1