MAUDE Adverse Event Report: CARDINAL HEALTH N-C CONN TUBE 5MM X3.0M; TUBING, NONINVASIVE

Model Number	8888301523
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	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: there were three cases where the blue grip came off during use.All three of the actual products are discarded due to blood adhesion and cannot be collected.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation because it was discarded due to contamination.
Additional Manufacturer Narrative
Please disregard this report number (9612030-2023-03762).Further information determined that an detachment of this device is not fda reportable.
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 5MM X3.0M
• Common Device Name: TUBING, NONINVASIVE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048 ; MX 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: 17327159
• Report Number: 9612030-2023-03762
• Device Sequence Number: 12172689
• Product Code: GAZ
• UDI-Device Identifier: 10884527019618
• UDI-Public: 10884527019618
• 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,Followup
• Report Date (Section B): 10/06/2023

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?: No
• Device Model Number: 8888301523
• Device Catalogue Number: 8888301523
• Device Lot Number: 2219612664
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 07/06/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/09/2023; 10/06/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown