MAUDE Adverse Event Report: CARDINAL HEALTH JACKSONVILLE CANISTER GUARDIAN 12LTR LVC; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651-120

Device Problems Fitting Problem (2183); Aspiration Issue (2883)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing device history record for lot number j704-915 provided by the customer was performed.The product was manufactured 04/08/2017.This investigation determined that all products were manufactured, inspected, and released in accordance to our established specifications for quality and efficacy.No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.However, four pictures were received from the customer for evaluation.A visual examination of the pictures was completed with production, engineering, and quality management.The picture depicted an assembled lvc unit which had not been used; however, we were unable to determine if the tabs of the lid were properly engaged prior to use.The lids are 100% manually placed on the canisters for the lvc product immediately prior to final packaging and any lid that did not have the locking tabs engaged would be readily apparent to the operator and corrected.Based on the investigation, our engineering department has determined that it is possible that the tabs of the lid could pop off during shipment and not be visibility apparent.For customer awareness, it is recommended that the customer review the unit for proper lid placement prior to use.Per the directions for use included with the product, during set up and use the customer should inspect the canister, lid, and components to ensure there is no damage from shipping, storage, or handling.The directions for use also instruct the user to make sure to engage all locking tabs.This includes visual instructions to press down firmly on the lid to make sure to engage all locking tabs that might have popped up during shipment.Although a specific assignable cause was not determined, a cross-functional team consisting of quality, production, and engineering management was assembled to explore action items to determine an assignable cause and corrective actions.These improvements were monitored and reviewed through our corrective and preventative action system.As part of the corrective action taken during the capa, a new gage was added to assist in the dimensional inspections.This new inspection will assist in determining the approved quality specification for ovality on the lids which will help to keep the lids locked in place during shipment and further use.This change was effective 09/13/2017.Based on the date of the manufacture of the reported lot number (04/08/2017), this product was manufactured prior to the implementation of that change.

Event Description

The lid did not fit properly to the canister resulting in loss of aspiration and visibility for the surgeon during adenoma prostate sampling procedure.It was reported that the adenomas were moving causing internal bleeding.

Manufacturer Narrative

A review of the manufacturing device history record for lot number provided was performed.The product was manufactured 04/08/2017.This investigation determined that all products were manufactured, inspected, and released in accordance to our established specifications for quality and efficacy.One sample was received after the completion of the investigation.A visual examination of the canister was completed by quality and engineering management.The returned unit did not have the lid properly sealed and was determined not be the actual event sample.Four pictures were received from the customer for evaluation.A visual examination of the pictures was completed with production, engineering, and quality management.The picture depicted an assembled lvc unit which had not been used and was later determined not to be the actual event samples.The lids are 100% manually placed on the canisters for the lvc product immediately prior to final packaging and any lid that did not have the locking tabs engaged would be readily apparent to the operator and corrected.Based on the investigation, our engineering department has determined that it is possible that the tabs of the lid could pop off during shipment and not be visibility apparent.For customer awareness, it is recommended that the customer review the unit for proper lid placement prior to use.Per the directions for use included with the product, during set up and use the customer should inspect the canister, lid, and components to ensure there is no damage from shipping, storage, or handling.The directions for use also instruct the user to make sure to engage all locking tabs.This includes visual instructions to press down firmly on the lid to make sure to engage all locking tabs that might have popped up during shipment.Although a specific assignable cause was not determined, a cross-functional team consisting of quality, production, and engineering management was assembled to explore action items to determine an assignable cause and corrective actions.These improvements were monitored and reviewed through our corrective and preventative action system.As part of the corrective action taken during the capa, a new gage was added to assist in the dimensional inspections.This new inspection will assist in determining the approved quality specification for ovality on the lids which will help to keep the lids locked in place during shipment and further use.This change was effective september 13, 2017.Based on the date of the manufacture of the reported lot number (04/08/2017), this product was manufactured prior to the implementation of that change.

• Brand Name: CANISTER GUARDIAN 12LTR LVC
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH JACKSONVILLE; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 7438342
• MDR Text Key: 105756066
• Report Number: 1423537-2018-00179
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00630140041207
• UDI-Public: 00630140041207
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 65651-120
• Device Catalogue Number: 65651-120
• Device Lot Number: J704-915
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2018
• Patient Sequence Number: 1