MAUDE Adverse Event Report: CARDINAL HEALTH N-C CONN TUBE 6MM X3.1M; 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	05/15/2023
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 the joint connector on the suction tube is disengaged.The product was not used.
Additional Manufacturer Narrative
H4 device manufacture date was added the device history record (dhr) review showed no discrepancy.One unused sample was received and inspected.A male connector detachment was observed.The reported condition was confirmed.A walk through was carried out in the manufacturing area and a risk assessment was performed.The exact root cause could not be determined.Production personnel received an awareness notification regarding the reported issue.This complaint will be used for tracking and trending purposes.

• Brand Name: N-C CONN TUBE 6MM 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: 16945316
• Report Number: 9612030-2023-03700
• Device Sequence Number: 17780803
• Product Code: GAZ
• UDI-Device Identifier: 20884527019653
• UDI-Public: 20884527019653
• 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): 09/27/2023

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: 8888301614
• Device Catalogue Number: 8888301614
• Device Lot Number: 2208851264
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown