MAUDE Adverse Event Report: CARDINAL 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.I suspect a bad adhesion, but please report if the same case occurs in the same lot.
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 (9612030-2023-03763).Further information determined that an detachment of this device is not fda reportable.

• Brand Name: N-C CONN TUBE 5MM X3.0M
• Common Device Name: TUBING, NONINVASIVE
• Manufacturer (Section D): CARDINAL; 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: 17327488
• Report Number: 9612030-2023-03763
• Device Sequence Number: 5523768
• 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
• Report Date (Section B): 07/14/2023

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: 2226412564
• 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
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 07/14/2023
• 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