MAUDE Adverse Event Report: CARDINAL HEALTH YANKAUER OPEN TIP W ON OFF CN; CATHETER AND TIP, SUCTION

Model Number	8888505172
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	05/18/2023
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 that during delivery from the distributor to the hospital, welded parts became dis-attached.The product was unused.Per additional information received, there was no medical intervention was required.
Additional Manufacturer Narrative
A decontaminated sample was received at the plant for the investigation.Because a lot number was not provided, the device history record could not be performed.Upon a visual evaluation of the sample, the defect was confirmed; the received sample detached easily.A root cause analysis indicated that the amount of solvent applied was not enough to prevent detachment as reported.

• Brand Name: YANKAUER OPEN TIP W ON OFF CN
• Common Device Name: CATHETER AND TIP, SUCTION
• 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: 17058277
• Report Number: 9612030-2023-03715
• Device Sequence Number: 12480559
• Product Code: JOL
• UDI-Device Identifier: 10884527020010
• UDI-Public: 10884527020010
• 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): 08/22/2023

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: 8888505172
• Device Catalogue Number: 8888505172
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/22/2023
• 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