MAUDE Adverse Event Report: CARDINAL HEALTH 16FR PEG ADAPTOR ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884751622E

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/02/2023

Event Type  malfunction  

Event Description

The customer reported that the hard plastic end of the main upright port broken off from the softer plastic y-section.The adapter was broken at home and was glued by family and the out patient clinic was notified.The adapter was replaced with a new one when the patient went in for a diagnostic test.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was received for evaluation and the reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported issue added the lot number to section d4.

• Brand Name: 16FR PEG ADAPTOR ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 17108084
• MDR Text Key: 317166184
• Report Number: 9612030-2023-03722
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521664050
• UDI-Public: 10884521664050
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884751622E
• Device Catalogue Number: 8884751622E
• Device Lot Number: 1909901264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• Type of Device Usage: A
• Patient Sequence Number: 1