MAUDE Adverse Event Report: CARDINAL HEAALTH DOBBHOFF 12FR 43IN W STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711253
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the protective cover for handling the guide wire (cap) came loose in the package.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
H4 device manufacturer date added evaluation summary: the device history record (dhr) review showed manufacturing and inspection of the product were performed as per applicable procedures and validated processes.A visual and functional inspection is performed for each batch prior to product release.A sample evaluation could not be performed because no sample nor photo was provided.The condition reported could not be confirmed.The root cause could not be determined without a sample to evaluate.No action plan is required at this point.The manufacturing site will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.

• Brand Name: DOBBHOFF 12FR 43IN W STYLET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEAALTH; 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: 16725987
• Report Number: 9612030-2023-03673
• Device Sequence Number: 18113727
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/22/2023

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: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 2129203764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/22/2023
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown