MAUDE Adverse Event Report: COVIDIEN AQUA-SEAL CDU; BOTTLE, COLLECTION, VACUUM

Model Number	8888571299
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that one of the hoses disconnected from the drain and cannot be reconnected as there is no vacuum generation in the circuit.There was no patient involvement.
Additional Manufacturer Narrative
Section d4 has been updated to reflect the corrected lot number (20a055fhx) provided by the customer. .
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One unused sample was received for the investigation.The sample was reviewed by production and quality personnel and the reported issue was confirmed; the patient tube was not pushed fully onto the vessel until it met the top of the vessel, causing it to lift.A root cause analysis determined that this issue occurred as a result of the standard work instructions not being correctly followed during assembly.The sample was shown to all operators trained on the work step and a quality alert was issued to heighten awareness.All operators trained on the process have completed role testing to ensure that they are completing the task correctly.This complaint will be used for tracking and trending purposes.

• Brand Name: AQUA-SEAL CDU
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 12100516
• Report Number: 9611018-2021-00517
• Device Sequence Number: 17347419
• Product Code: KDQ
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 10/15/2021

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
• Operator of Device: No Information
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 20A055FHX
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 06/30/2021; 06/30/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/23/2021; 10/15/2021
• Patient Sequence Number: 1