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

Model Number 8888571299

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  malfunction  

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 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.

Manufacturer Narrative

Section d4 has been updated to reflect the corrected lot number (20a055fhx) provided by the customer. .

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
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 12100516
• MDR Text Key: 259406460
• Report Number: 9611018-2021-00517
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 20A055FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/30/2021
• Patient Sequence Number: 1