MAUDE Adverse Event Report: CARDINAL HEALTH SUCTION YANKAUER CLEAR BULB TIP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	K86
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	12/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Clinical staff reported that over the week the tip of a yankauer suction device broke during use.The tip was lodged in the patient¿s airway and was fortunately able to be removed.Staff reported that there isn't much force applied during the procedures and others said they never experienced one breaking before.There was no patient injury reported and it is unknown if medical intervention was required.
Additional Manufacturer Narrative
Five (5) samples; four (4) in their original packaging identified with the part and lot number and one (1) part containing a piece a yankauer suction tip inside a ziploc bag were received at the manufacturing site.In addition, 9 digital images were submitted for analysis.After performing a visual inspection according to the product specifications, the reported condition is observed; the yakauer suction tip is detached.The investigation concluded that the most likely root cause was due to an inhomogeneous mix of components (k-resin, styrene, zinc).An engineering study was developed to test a gravimetric mixture, to verify the mix process of resin used on the product, with the percentage of the resin mixture as specified in the bill of material.A quality alert has been issued to heighten awareness to all personnel involved in the process to mitigate a reoccurrence of the reported issue.

• Brand Name: SUCTION YANKAUER CLEAR BULB TIP
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 13293463
• Report Number: 9612030-2022-03140
• Device Sequence Number: 4547406
• Product Code: GCX
• UDI-Device Identifier: 00885380030157
• UDI-Public: 00885380030157
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: K86
• Device Catalogue Number: K86
• Device Lot Number: 1929508764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/15/2022
• 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