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

Model Number	8888505016
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 reports the plastic connection appears to have melted causing diminished suction.There was no harm to the patient.
Additional Manufacturer Narrative
Additional information: a picture was provided for evaluation.An evaluation of the picture showed the yankauer is deformed.The reported condition has been confirmed.After reviewing our database, the lot number reported by the customer was invalid.Therefore, a device history record (dhr) review was not possible since the lot number does not correspond and is not recorded in a product code.The evaluation has been performed based on the provided photo.With this we can conclude that the most likely root cause could occur during the assembly process; the parts are molded and then sent to the packaging process.The current molding process conditions were reviewed, and it was confirmed that all manufacturing procedures are being followed properly.A potential cause of the reported condition could occur during the molding process due to an excess of heat in the cores of the tool.The current process is running according to product specifications and meeting quality acceptance criteria.Since the reported condition was not identified during the manufacturing process and a potential root cause was identified, preventive actions will be implemented to assure this condition does not repeat.A quality alert was issued to notify personnel of the reported condition.Preventive maintenance had been initiated through a job plan and is being carried out with a bi-monthy frequency.

• 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: 8708458
• Report Number: 9612030-2019-02204
• Device Sequence Number: 2072866
• Product Code: GCX
• UDI-Device Identifier: 10884527019946
• UDI-Public: 10884527019946
• 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,Followup
• Report Date (Section B): 10/21/2019

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
• Operator of Device: No Information
• Device Model Number: 8888505016
• Device Catalogue Number: 8888505016
• Device Lot Number: 18118206364
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 10/21/2019
• Patient Sequence Number: 1