MAUDE Adverse Event Report: CARDINAL HEALTH N-C CONN TUBE 7MM X3.1M; TUBING, NONINVASIVE

Model Number	8888301713
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during operation, the suction did not work.When confirming, it looked like a film was formed inside the connecting part on one end; period of use was a few minutes.There was no patient injury reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on april 8, 2022.The sample was received for the analysis.Upon analysis, the reported issue was confirmed.The analysis of the sample was carried out with the multifunctional team, an occlusion could be observed.The reported issue was confirmed.The sample was sectioned to get a better view.The occlusion was caused by something like a pill inside the tube.A gemba walk was carried out in the manufacturing area with the multifunctional team and determined that the reported issue didn¿t occur at the manufacturing floor.The most probable root cause is that the occlusion was caused during the use of the product.No corrective actions are deemed necessary at this time, as the reported issue was not related to manufacturing process.

• Brand Name: N-C CONN TUBE 7MM X3.1M
• 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: 17799219
• Report Number: 9612030-2023-03832
• Device Sequence Number: 6954193
• Product Code: GAZ
• UDI-Device Identifier: 10884527019700
• UDI-Public: 10884527019700
• 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): 12/19/2023

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?: Yes
• Device Model Number: 8888301713
• Device Catalogue Number: 8888301713
• Device Lot Number: 2208853064
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown