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

Model Number	8884710826
Medical Device Problem Codes	Difficult to Remove (1528); Obstruction of Flow (2423); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2023-03532
• Device Sequence Number: 6852062
• Product Code: KNT
• UDI-Device Identifier: 10884521518742
• UDI-Public: 10884521518742
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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: 8884710826
• Device Catalogue Number: 8884710826
• Device Lot Number: 1925204164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown