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 Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

Device manufacture date: nov-2018.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 shortly after started using the product on a patient, it was noticed that they had not been able to perform suction.The customer further mentioned that there was a back-flow observed, so they immediately stopped using it.There was no patient harm reported.

Manufacturer Narrative

Evaluation summary: 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 open and unused sample was returned to the manufacturing site for evaluation.The sample was visually inspected with no issues found.The sample was tested to try and identify any potential issues with the device.The sample would not regulate for suction.Following completion of all testing on the sample, the regulator connector was removed from the sample and visual inspection was completed.There was no issue detected with the regulator connector other than the presence of a small amount of glue on the umbrella valve which is located under the regulator connector.As per standard work instructions, a small amount of glue is to be placed so as the entire circumference of the regulator insert area is covered.From the review of the sample and the presence of glue on the umbrella valve it has been determined that excess glue may have been placed on the regulator connector causing the glue to spill on to the umbrella valve which may have caused the reported condition.The vessel could start to work, but the glue may have contributed to losing suction.Production personnel have been made aware of the customer complaint through a quality alert and refresher training was completed with all employees that complete the gluing process to ensure they supply the correct amount of glue on the regulator connector.At this time, a corrective and preventative action (capa) will not be initiated.The manufacturing site will continue to monitor the process for any adverse trends that require immediate attention.The associated data will be fed into the risk management quarterly report.This complaint will be used for 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: 11664117
• MDR Text Key: 245552840
• Report Number: 9611018-2021-00503
• 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
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888571562
• Device Catalogue Number: 8888571562
• Device Lot Number: 18K108FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/05/2021
• Patient Sequence Number: 1