MAUDE Adverse Event Report: COVIDIEN ARGYLE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888501023
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	03/07/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the product had very little curvature and the surgeon could not suck the blood properly in the throat of a child; causing respiratory distress.
Additional Manufacturer Narrative
An investigation was performed for the reported customer complaint: ¿the customer reported that the product had very little curvature and the surgeon could not suck the blood properly in the throat of a child; causing respiratory distress.¿ the customer relayed the status of the patient as doing well.The customer could not confirm if any treatments/medications were provided for the respiratory distress or how the respiratory distress was corrected.A review of the device history records (dhr) for reported lot number 1712221264 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No physical samples or pictures were submitted for evaluation.Therefore, a comprehensive product investigation was unable to be conducted.However, preliminary investigation discovered that customers have received products that were not approved in europe.These products were inadvertently shipped, most likely due to a logistics and inventory distribution issue.Once manufactured, this product leaves the manufacturing site and is processed by the logistics and supply chain markets.There is no apparent correlation to the reported event and the logistics issue.It is also unclear if the customer experienced the logistics issue.A capa has been opened to address this issue at the corporate level.Additionally, a product hold has been put in place as a containment action and an issue impact assessment (iia) has been performed.Due to no product/sample being provided for evaluation, the reported customer complaint could not be confirmed.A root cause for the reported customer complaint could not be determined.A probable root cause for product shipment was determined to be a logistics and inventory distribution issue.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana 22444 ; MX 22444
• MDR Report Key: 7373712
• Report Number: 9612030-2018-00041
• Device Sequence Number: 13880738
• Product Code: GCX
• UDI-Device Identifier: 20884527019844
• UDI-Public: 20884527019844
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 8888501023
• Device Catalogue Number: 8888501023
• Device Lot Number: 1712221264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 10/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other