MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 12FR 43IN W STYL YPOR; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	8884721252E
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	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the doctor was inserting the nasogastric tube and when he went to remove the stylet the purple end came off and the wire struck the doctor in the finger piercing the glove.The doctor was ok, no injury occurred.Additional information received on 21aug2023 stated that the nasogastric tube was not flushed with water prior to stylet removal.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event as the device history record was reviewed and indicated that the product was released accomplishing all quality standards.Furthermore, the reported issue could not be confirmed from the returned sample.No corrective actions are required at this time.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: ENTRFLX 12FR 43IN W STYL YPOR
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 17627861
• Report Number: 9612030-2023-03815
• Device Sequence Number: 17971696
• Product Code: PIF
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 213060364
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown