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

Model Number	8888505016
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they have discovered that the yankauers being stocked all have the same reference number, but some have holes in them and some do not.The blue ones they used to stock never had holes, you simply plug it into the suction tubing and it works.The one with the hole, however, does not suction adequately unless you put your finger over the hole.Additional information received on (b)(6) 2022 stated that the issue was found during patient use however the quantity of involved patients is unknown and no individual incident information is available.There were no known injuries or harm.The customer further stated that this is the model of yankauers they have always used.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record for lot number 2128512164 was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Two samples were received for evaluation, one from the reported lot number and one representative sample from lot 2109607864.A visual inspection of the received samples was carried out according to the procedure.The representative sample from lot 2109607864 meets specifications however the sample from the reported lot number 2128512164 did not meet specifications; the reported issue was confirmed.A corrective and preventive action has been initiated to address the reported issue.

• Brand Name: YANKAUER REGULAR CAPACITY BULB
• 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: 13444129
• Report Number: 9612030-2022-03151
• Device Sequence Number: 4492552
• Product Code: GCX
• UDI-Device Identifier: 10884527019946
• UDI-Public: 10884527019946
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/01/2022

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: 8888505016
• Device Catalogue Number: 8888505016
• Device Lot Number: 2128512164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown