MAUDE Adverse Event Report: CARDINAL HEALTH N-C CONN TUBE 6MM X3.0M; TUBING, NONINVASIVE

Model Number	8888301614
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	01/09/2024
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 the suction tubing will not remain intact to a scope or medical device causing a potential exposure to blood and body fluids, and a patient safety hazard.
Additional Manufacturer Narrative
H4 device manufacture date was added.The device history record (dhr) review showed no discrepancy.One unused sample with the reported lot number was received for evaluation.After performing a visual inspection and functional testing, it was found that the product complies with the specifications according to acceptance criteria of the manufacturing process.The reported condition could not be confirmed.A possible root cause cannot be determined with the available information.No action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.This complaint will be used for tracking and trending purposes.

• Brand Name: N-C CONN TUBE 6MM X3.0M
• 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: 18797890
• Report Number: 9612030-2024-00041
• Device Sequence Number: 17965679
• Product Code: GAZ
• UDI-Device Identifier: 20884527019653
• UDI-Public: 20884527019653
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/01/2024

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: 8888301614
• Device Catalogue Number: 8888301614
• Device Lot Number: 2311108864
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown