MAUDE Adverse Event Report: CARDINAL HEALTH N-C CONN TUBE 7MM X1.8M; TUBING, NONINVASIVE

Model Number	8888301705
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	12/08/2023
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 before use they observed that the blue part had been disengaged.There was no patient use.
Additional Manufacturer Narrative
Device manufacture date was added the device history record (dhr) was reviewed showing no discrepancy.One physical sample was received for evaluation.The sample was visually inspected with the multifunctional team and a detachment was observed between the sure grip and the tube due to missing of solvent.The reported issue was confirmed.A walk through of the process was performed showing the current process was running according to approved specifications.However, because the tube assembly is performed manually, manufacturing will perform functional tension and leakage tests before product release.A retraining of personnel was carried out and a quality alert was issued.This complaint will be used for tracking and trending purposes.

• Brand Name: N-C CONN TUBE 7MM X1.8M
• 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: 18397806
• Report Number: 9612030-2023-03885
• Device Sequence Number: 2646343
• Product Code: GAZ
• UDI-Device Identifier: 20884527019691
• UDI-Public: 20884527019691
• 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): 07/02/2024

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: 8888301705
• Device Catalogue Number: 8888301705
• Device Lot Number: 2224905864
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown