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

Model Number	8884751622E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2023-03722
• Device Sequence Number: 2250710
• Product Code: PIF
• UDI-Device Identifier: 10884521664050
• UDI-Public: 10884521664050
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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: 8884751622E
• Device Catalogue Number: 8884751622E
• Device Lot Number: 1909901264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown