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

Model Number 8888571562

Device Problem Suction Problem (2170)

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

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 they had an issue with the suction function.Liquid from the different chambers were mixed with the water seal chamber.The system is very unstable and overturns easily as it is high and narrow, despite the foot that can be put across the bottom of the devise.The chamber where sterile water is filled to the water trap, is specified to click when closed to ensure proper and tight closure; however, it did not close tightly.The lack of correct function prolongs treatment and hospital stay.The customer further reported that there was no medical intervention as a result of this issue.

Manufacturer Narrative

Date received by manufacturer the aware date was inadvertently entered as (b)(6) 2021 but should have been (b)(6) 2021 because this is the date we were made aware there was additional incidences.

Manufacturer Narrative

A device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.(b)(4) representative sample in its original packaging was received at the manufacturing site; this sample was used to investigate one of eight complaints received for the same customer and reported issue.The sample returned for investigation is from a different lot number than what was originally reported.There has been no design change to the sentinel seal units therefore the high and narrow body of the units are correct.There is an adjustable foot stand with each unit which can be rotated to 90o for additional stability of the device when it is placed on a flat surface.Additionally, there is a hook supplied with each unit that allows the device to be hung form the bedside of a patient negating the requirement to place the unit seated on a flat surface.Each unit is 100% functionally tested and inspected prior to packaging to ensure full functionality of the device and that all components are present on the sentinel seal unit prior to packaging and sterilization.The returned unit passed all testing and did not confirm the reported issue.At this time, a formal corrective/preventative action (capa) is not deemed necessary since the root cause of the reported event cannot be confirmed.We will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: S.S. CDU
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 11359222
• MDR Text Key: 232858881
• Report Number: 9611018-2021-00480
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10884521061026
• UDI-Public: 10884521061026
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888571562
• Device Catalogue Number: 8888571562
• Device Lot Number: 91245FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization