MAUDE Adverse Event Report: CARDINAL HEALTH ENTFLX 12FR 43IN W STYL YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/01/2023
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 the tube was inserted into the patient and the stylet wire was discarded.The wire punctured the doctor's thumb during removal.Additional information received stated the green cap covering the end of the wire fell off and the wire punctured the doctor's thumb.The doctor left the case, washed his hands, and applied a band aid.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date was added.The device history record (dhr) was reviewed showing no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.Sample evaluation could not be performed because no sample nor photo was available for evaluation.A walk through was performed of the manufacturing process.Process and controls were found properly followed.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: ENTFLX 12FR 43IN W STYL YPORT
• 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: 17078245
• Report Number: 9612030-2023-03717
• Device Sequence Number: 12344510
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 2204101164
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/03/2023
• Date Device Manufactured: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown