MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 8FR 55 W STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884710826

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Difficult or Delayed Separation (4044)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that this product is clogging frequently (even though medications are not being administered through them) and when guide wire is inserted it is difficult to remove.One rn reported that the guide wire being hard to remove has happened with two different tubes.Apparently the staff are using 2-3 before they find one that actually works.There was no patient injury reported.Per additional information received, they followed instructions of instilling 10 ccs of normal saline prior to insertion and was still not able to withdraw the guidewire.There was no harm done to the patient.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on september 18, 2019.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.The investigation was carried out with the multifunctional team, all processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.If a sample is received at a later date, the investigation will be updated accordingly.A corrective action is not applicable at this time.We will continue to monitor for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.Correction made to h6 medical device problem code to display 4044 "difficult or delayed separation" rather than 1528 "difficult to remove".

• Brand Name: DOBBHOFF 8FR 55 W STYLET
• Type of Device: 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: 16233718
• MDR Text Key: 308634449
• Report Number: 9612030-2023-03532
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518742
• UDI-Public: 10884521518742
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884710826
• Device Catalogue Number: 8884710826
• Device Lot Number: 1925204164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1