MAUDE Adverse Event Report: CARDINAL HEALTH 20FR PEG ADAPTOR ENFIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884752042E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the replacement fitting has cracked.After being at the client, it would appear that the caregivers use two forceps to open the cap that is used to close the nutrition port.Additional information received stated the device was leaking formula due to the issue.There was no patient harm.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number was not available.Sample analysis could not be performed because no samples were provided.Two photos were provided for evaluation.In the photo, the y-port was broken at the junction.The reported condition was confirmed through the photos; however, the reported condition could not be confirmed as related to the manufacturing process through the photo evaluation.A walk through was performed in the manufacturing area.There is currently no part of the manufacturing process that could cause a broken y-port.The root cause could not be determined.A review of the manufacturing process, customer complaint history, corrective action board and management review metrics and trends, acceptance sampling plans, provided pictures, as well as risk management procedures was performed.A corrective and preventative action (capa) has been opened to further investigate the issue.The manufacturing site will continue to monitor customer complaints and feedback notifications.In case of repeated issues and/or reoccurrence, a new investigation for the specific events would be carried out for each case.This complaint will be used for tracking and trending purposes.

• Brand Name: 20FR PEG ADAPTOR ENFIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 13577505
• Report Number: 9612030-2022-03172
• Device Sequence Number: 20254200
• Product Code: KNT
• UDI-Device Identifier: 30884521664061
• UDI-Public: 30884521664061
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/25/2022

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: 8884752042E
• Device Catalogue Number: 8884752042E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/25/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown