MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 20FR EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884720205E

Device Problem Deflation Problem (1149)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

The customer reported they have a (b)(6) female patient with a diagnosis of cardiac arrest with successful resuscitation.The patient is under management with a 20fr gastrostomy tube which has a damaged balloon.The device was removed.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.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.The investigation was carried out with the multifunctional team.All processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.A risk assessment was carried out.The observed occurrence is below the range of the expected occurrence; therefore, no action plan is required at this point.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 20FR EN
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 14218280
• MDR Text Key: 290151731
• Report Number: 9612030-2022-03232
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720205E
• Device Catalogue Number: 8884720205E
• Device Lot Number: 2118109264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2022
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Sex: Female