MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR;43IN W/STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721088
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that after insertion of the product by multiple highly skilled staff, the guidewire becomes stuck and is extremely difficult to remove even with flushing as recommended trouble shooting.The guide wire has a sticky feel as you withdraw it as if it is getting stuck on the inside of the tube.This has caused the tube to become dislodged and coil, requiring a new product second or even third re-insertion as the next product will have the same occurrence.Per additional information received, there was no patient injury or death reported.The patient required extra insertion due to the alleged issue.There was no change reported in the current status of the patient.Also, it was confirmed with clinical staff they are submerging the tube in water for 5 seconds prior to inserting it.
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.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 01-jun-2021.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.During the investigation, a review through the manufacturing process was conducted.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.At this time, a corrective and preventive action is not deemed necessary.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: ENTRFLX 10FR;43IN W/STY YPORT
• 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: 13061944
• Report Number: 9612030-2021-03125
• Device Sequence Number: 1426989
• Product Code: KNT
• UDI-Device Identifier: 10884521518872
• UDI-Public: 10884521518872
• 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): 02/03/2022

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: 8884721088
• Device Catalogue Number: 8884721088
• Device Lot Number: 2114502764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown