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	12/15/2023
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 that the blue connector disengaged easily.It does not appear to be barely glued.Per additional information received, there was no medical intervention required.The product was unused.
Additional Manufacturer Narrative
A decontaminated sample was received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the sample, the reported issue was confirmed; there was a detachment between the sure grip and the tube.The root cause is unknown at this time.

• 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: 18425783
• Report Number: 9612030-2024-00001
• Device Sequence Number: 7771508
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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
• Device Model Number: 8888301606
• Device Catalogue Number: 8888301606
• Device Lot Number: 2315320764
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 07/11/2024
• 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