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

Model Number	8884752042E
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the yellow piece came out and will not stay in.Per additional information provided on 1/23/23, the product appears to have leaked as it did not fit snuggly.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluation comment - the customer stated that the device will not be returned for evaluation because it was in use.
Additional Manufacturer Narrative
A review of the device history record could not be conducted as the lot number was reported as unknown.A photograph was submitted for evaluation; a leak is observed; the reported condition is confirmed.Disassembly and leakage were confirmed through the photo sample.During the investigation, a review of the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.The root cause for the reported condition could not be determined without a physical sample to evaluate.The manufacturing site will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.An awareness notification was issued to production personnel to heighten awareness of the condition reported through a quality alert.

• Brand Name: 20FR PEG ADAPTOR ENFIT
• Common Device Name: 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: 16225551
• Report Number: 9612030-2023-03529
• Device Sequence Number: 5351421
• Product Code: KNT
• UDI-Device Identifier: 30884521664061
• UDI-Public: 30884521664061
• 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): 03/21/2023

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: 8884752042E
• Device Catalogue Number: 8884752042E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown