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	08/19/2022
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 the tip of the mandrel (guide wire) came off and pierced an employee's finger.It is the third occurrence with the same batch of this sne.The material was used according to the manufacturer's instructions, but the problem continues to occur.
Additional Manufacturer Narrative
A device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.A sample analysis was not possible as there was no photographs or samples provided for evaluation.Without a sample to evaluate, it is not possible to confirm the reported issue or related it to a manufacturing process.All associated lot documentation was carefully reviewed; no issues or discrepancies were found related to the reported complaint.Current process controls are executed in accordance with product specifications to meet quality acceptance criteria.The manufacturing facility will continue to monitor the process, customer complaints and feedback notifications for any adverse trends that require immediate attention.In the case of a repeated issue and/or recurrence, a new investigation for the specific events would be carried out for each case.

• 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: 16382295
• Report Number: 9612030-2023-03548
• Device Sequence Number: 5898528
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• 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): 03/23/2023

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: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown