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

Model Number 8884752505

Device Problems Complete Blockage (1094); Material Twisted/Bent (2981)

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

Event Date 09/06/2021

Event Type  malfunction  

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 Description

The customer reported that the tube kinked while the user was inserting the tube into the patient.No patient injury reported.

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.

Manufacturer Narrative

Additional information was received from the initial reporter.Based on the information received, the following sections were updated: added additional incident information to section b5 describe event or problem; added patient information in section a; added medical device problem code 1094 medical device problem code in section h6; added 4629 device revision or replacement in section h6.Corrected the event date in section b3 date of event.
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Event Description

The customer reported that the tube kinked while the user was inserting the tube into the patient.No patient injury reported.Additional information received from the customer on (b)(6) 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 a change of the nj feeding tube.

• Brand Name: 12FR ENDO TB FOR ENDOSCPIC PLC
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12636961
• MDR Text Key: 276617075
• Report Number: 9612030-2021-03063
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 30884521009664
• UDI-Public: 30884521009664
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884752505
• Device Catalogue Number: 8884752505
• Device Lot Number: 1911903064
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 30