MAUDE Adverse Event Report: CARDINAL HEALTH FLEXIBLE YANKAUER REGULAR CAPA; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888501015
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 during a total abdominal hysterectomy in laparotomy, the cannula basket detached in the patient's abdominal cavity, and was promptly recovered.
Additional Manufacturer Narrative
The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process for the reported lot.One (1) sample was returned.As part of the investigation, the team inspected both the catheter and the sump tip under magnification and confirmed the presence of the bonding agent.This would allow for the sump tip to be bonded to the catheter.A review did not identify any damage on the tip that would suggest it was damaged during production.As part of the assembly process, the sump tip is inspected by the operator to ensure that the sump tip is fully seated down on the yankauer.Post assembly of the sump tip and catheter, each individual unit is subjected to a 100% static weight pull test to ensure the catheter and tip is bonded correctly.No definitive root cause could be identified.At this time, a corrective and preventative action (capa) will not be initiated.Complaint trending will continue to be monitored.

• Brand Name: FLEXIBLE YANKAUER REGULAR CAPA
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18747629
• Report Number: 9611018-2024-00010
• Device Sequence Number: 19758627
• Product Code: GCX
• UDI-Device Identifier: 10884527019830
• UDI-Public: 10884527019830
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/14/2024

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: 8888501015
• Device Catalogue Number: 8888501015
• Device Lot Number: 23C100FHX
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown