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

Model Number	8888501015
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it was discarded; 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 unit is not adequate to suction the blood and blood clots, despite the cannula being changed.The patient had prolonged bleeding and increased severe blood loss.The patient did not require a blood transfusion.No other information is available at this time.

• Brand Name: FLEXIBLE YANKAUER REGULAR CAPA
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 9263276
• Report Number: 9611018-2019-00358
• Device Sequence Number: 1879096
• Product Code: GCX
• UDI-Device Identifier: 10884527019830
• UDI-Public: 10884527019830
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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: 8888501015
• Device Catalogue Number: 8888501015
• Device Lot Number: 19A152FHX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/31/2019
• Patient Sequence Number: 1