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

Model Number 8884721252

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event 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.

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
• 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: 17078245
• MDR Text Key: 316679289
• Report Number: 9612030-2023-03717
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 08/03/2023
• Date Device Manufactured: 02/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1