MAUDE Adverse Event Report: CARDINAL HEALTH 12FR ENDO TB FOR ENDOSCPIC PLC; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884752505
Medical Device Problem Codes	Complete Blockage (1094); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the tube kinked while the user was inserting the tube into the patient.No injury reported.
Additional Manufacturer Narrative
Additional information was received from the initial reporter.Based on the information received, the following sections were updated: added medical device problem code 1094 medical device problem code in section h6; added 4629 device revision or replacement in section h6.
Event or Problem Description
The customer reported that the tubes kinked while the user was inserting the tube into the patient.No patient injury.Additional information received from the customer on 13-oct-2021 stated that the nj feeding tube was inserted on (b)(6) 2021, and kinked at one of the side holes on (b)(6) 2021, resulting in a block tube requiring changing of the nj feeding tube.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A physical sample was not returned; however, photos were provided for evaluation.After performing visual inspections of the photos, it appears the tube is kinked however, it is not possible to confirm the reported issue based on the photos alone.The physical sample is required to assess and confirm the reported issue.An investigation was carried out with the multifunctional team.All processes were reviewed.All processes and controls were found to be properly followed, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.Based on all available information, the issue reported was not confirmed and an action plan is not considered necessary at this time.The current process is executed in accordance with product specifications that meet quality acceptance criteria.We will continue to monitor the process for any adverse trends that require immediate attention.

• Brand Name: 12FR ENDO TB FOR ENDOSCPIC PLC
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12636719
• Report Number: 9612030-2021-03062
• Device Sequence Number: 11892659
• Product Code: KNT
• UDI-Device Identifier: 30884521009664
• UDI-Public: 30884521009664
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2021

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
• Operator of Device: No Information
• Device Model Number: 8884752505
• Device Catalogue Number: 8884752505
• Device Lot Number: 1911903064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 10/05/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 10/25/2021; 11/03/2021
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 39