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

Model Number	8888501015
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2019
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 tip fell down during surgery.The surgeon managed to get it back.No injury on the patient.
Additional Manufacturer Narrative
The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of the reported lot number.One sample with detached sump tip was returned for the investigation.The sample was not in its original package.During the visual inspection, it was observed that there was no evidence of the bonding agent cyclohexane puriss present on either the tip of the suction catheter or the inside surface of the sump tip.As a result of visual inspection, the reported condition is confirmed.The root cause of the reported issue is non-application of cyclohexane puriss (bonding agent) on catheter.A corrective and preventive action (capa) has been opened to implement effective solutions to prevent reoccurrence of this issue.Upon receipt of the customer complaint, a quality alert was raised in the manufacturing area, where the suction catheter is manufactured and required personnel were trained on this quality alert making employees aware of the complaint.

• 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: 9476765
• Report Number: 9611018-2019-00374
• Device Sequence Number: 19495116
• Product Code: GCX
• UDI-Device Identifier: 10884527019830
• UDI-Public: 10884527019830
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 8888501015
• Device Catalogue Number: 8888501015
• Device Lot Number: 19D257FHX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other