MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 10FR 43IN W STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711006
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
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 3 tubes were disposed of as they were non-functional.Additional information received stated the mandrel (guidewire) in the center of the tube cannot be pulled out.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date added b4 additional information received was added to the event description the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.A sample analysis could not be performed because no photo or sample was available for evaluation.The complaint will be reopened if sample is received.A root cause cannot be determined.A walk through of the manufacturing process was carried out.Current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.No abnormal conditions were found that could trigger the reported condition.No action plan is required at this point.The manufacturing site will continue to monitor customer complaint and feedback notifications for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.
Event or Problem Description
Additional information received: the intensive care rn stated there does not seem to have been any problem with this product and therefore no harm to a user.It is a product rarely used by the rn.

• Brand Name: DOBBHOFF 10FR 43IN 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: 15923723
• Report Number: 9612030-2022-03484
• Device Sequence Number: 5486042
• Product Code: KNT
• UDI-Device Identifier: 10884521518780
• UDI-Public: 10884521518780
• 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): 01/04/2023

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: 8884711006
• Device Catalogue Number: 8884711006
• Device Lot Number: 2016102064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/04/2023
• Date Device Manufactured: 06/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown