MAUDE Adverse Event Report: CARDINAL HEALTH ENTFLX 12FR;43IN W/STYL YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721252

Device Problem Material Twisted/Bent (2981)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

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

Customer reports: the tube showed resistance when administering the drug.When it was removed it had a fold in it.

Manufacturer Narrative

The device history record (dhr) was reviewed and showed that the item code associated with the provided lot number of 2021701964 is 8884711253, not 8884711252.The device associated with this lot number was manufactured on august 11, 2020, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue reported.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated sample of item code 8884721252 without the original packaging or lot number was received for the investigation.In addition, a video was provided.An evaluation was performed, and the reported issue could not be confirmed at this time.Water was introduced on both sides of the adapter without any problems, no resistance was found, and the tube did not present any folds.The case was reviewed with the multi-functional team and all processes and controls were found properly followed, including sub-assemblies, finished product assembly, and packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.We will continue to monitor the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTFLX 12FR;43IN W/STYL YPORT
• Type of Device: 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 ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12053616
• MDR Text Key: 260935481
• Report Number: 9612030-2021-02965
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 2021701964
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1