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

Model Number	8888301614
Medical Device Problem Codes	Decrease in Suction (1146); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
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 does not provide a tight seal when attached to the scopes.The tubing falls off regularly and the suction strength is significantly impacted due to a loose seal.They can not clear the gi tract of liquid quickly, which can be life threatening if there is a significant bleed.
Additional Manufacturer Narrative
The device history record (dhr) review showed no discrepancy.One unused sample with lot number 2315323064 was received for evaluation.After performing a visual inspection and functional testing, the product complies with the specification according to acceptance criteria of the manufacturing process.The reported condition could not be confirmed.Based on the information available in this complaint report, the sample was manufactured according to current product specifications and tested under the current acceptance criteria; therefore, a possible root cause cannot be determined.No action plan is deemed required.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: 18562819
• Report Number: 9612030-2024-00027
• Device Sequence Number: 8124788
• 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): 04/05/2024

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
• 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: 01/15/2024
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown