MAUDE Adverse Event Report: CARDINAL HEALTH N-C CONN TUBE 6MM X1.8M; TUBING, NONINVASIVE

Model Number	8888301606
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	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the sure-grip comes off.About 80% of the product disengages from the sure-grip, thus, the customer uses the product by cutting off the sure-grip part.The period of use is 1 to 3 days.There was no patient injury.Per additional information provided on (b)(6) 2023, the sure grip has been identified as the blue connector which did detach.It appears that the connector was loose, most likely due to insufficient adhesive.There was no medical intervention required.The number of patients is unknown.
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.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: N-C CONN TUBE 6MM X1.8M
• Common Device Name: TUBING, NONINVASIVE
• 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: 17698337
• Report Number: 9612030-2023-03818
• Device Sequence Number: 7510766
• Product Code: GAZ
• UDI-Device Identifier: 10884527019649
• UDI-Public: 10884527019649
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 8888301606
• Device Catalogue Number: 8888301606
• Device Lot Number: 2303409264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/11/2023
• 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