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

Model Number 8888505016

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  malfunction  

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 Description

The customer reported that they yankauer suction device was found to be missing the distal rounded end of the tip after using it the second time.The yankauer was used immediately after intubation by doctor.It was not noticed at the time that the yankauer was flawed.The flaw was discovered during the emergence phase.A new yankauer was used.The doctor visualized the airway post procedure with glidescope and no yankauer tip was found.Additional information provided on april 01, 2021 stated that there was no difficulty during suctioning.There was no injury to the patient and there were no signs of airway obstruction or respiratory distress.The glidescope was used to visualize the hypopharynx following the procedure but no tip was observed and no additional medical intervention was required.

Manufacturer Narrative

A review of the device history record revealed no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no samples provided for evaluation, however two photographs were submitted for evaluation.The photographs were visually inspected and the reported condition was confirmed to be an incomplete yankauer.An investigation was conducted with a multifunctional team.The manufacturing process was reviewed.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.The most likely root cause is due to a workmanship issue; an inadequate segregation by the operator.As a precautionary measure, the personnel involved in the manufacturing process were re-trained on the procedure and a quality alert was generated notifying the personnel in order to heighten awareness of the reported condition.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: YANKAUER REGULAR CAPACITY BULB
• Type of Device: 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: 11648888
• MDR Text Key: 244897564
• Report Number: 9612030-2021-02849
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10884527019946
• UDI-Public: 10884527019946
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

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 Operator: No Information
• Device Model Number: 8888505016
• Device Catalogue Number: 8888505016
• Device Lot Number: 2001404564
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 07/01/2021
• Patient Sequence Number: 1