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

Model Number	8888505024
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the yankaeur suction bulb tip sheared off or was missing.They are unsure whether this was before use.Additional information received stated there was only one yankaeur affected.The staff members concerned do not think that any of the tip was left in the patient.The patient did however receive a video bronchoscope and cmac laryngoscopy while still anaesthetized and intubated to inspect and confirm any evidence of any plastic remaining.No evidence of a foreign body was found.There was no harm to the patient.

• Brand Name: YANKAUER REGULAR CAPACITY BULB
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12338949
• Report Number: 9612030-2021-03031
• Device Sequence Number: 20011776
• Product Code: GCX
• UDI-Device Identifier: 10884527019953
• UDI-Public: 10884527019953
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8888505024
• Device Catalogue Number: 8888505024
• Device Lot Number: 2028800564 20288005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other