MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT CANISTER GUARDIAN 3000CC; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651-230

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Four broken pieces of a canister were received for investigation after decontamination at an offsite facility.After a visual examination of the returned pieces by quality and engineering management, the pieces were determined to be the side wall of the canister.The returned pieces were measured by our laboratory personnel for high and low wall thickness and were found acceptable according to our quality specifications.As part of normal production controls, high and low side wall and bottom wall thickness measurements are completed for the guardian canisters each month.A review of the measurements since january 2018 found all inspections to be acceptable to quality specifications.No lot number was provided by the customer; therefore, a review of the manufacturing device history record to determine if any deviations took place during the manufacture of the product could not be performed.One possible failure mode is damage to the canister which could have occurred during transit and handling at the site.If the canister had a crack before applying suction, this would prevent the unit from functioning as intended and could cause the unit to implode.This type of damage could occur due to adverse shipping conditions or possible breakage during internal processing and final packaging.Examples include dropping the case or stack, rough handling, or forceful blows, which may cause excessive vibration, transmit a damaging force to the canisters or lids, or result in movement of the contents resulting in canister or lid damage.Packaged canisters or lids, when they are opened at the customer site, may exhibit the cracked unit although no apparent damage is evident on the outside of the box itself.If the unit was damaged prior to shipping, this unit was not included in any inspection sampling or noted during other processing steps.Testing at both the cardinal health manufacturing facility and our packaging technology center demonstrated positive results for the current packaging.With the information provided, no specific assignable cause can be determined based on the product design or manufacturing conditions.If the canister had a crack before applying suction, this would prevent the unit from functioning as intended and could cause the unit to implode during use.Per the directions for use included with the product, canisters, lids, and components should be inspected for damage from shipping, storage, or handling prior to use.If the canisters were exposed to static vacuum for prolonged periods of time, this would greatly increase the likelihood of the unit to implode during use.Per the directions for use included with the product, it is not recommended to subject the canister to vacuum when not in use.No further action is planned at this time.

Event Description

The suction canister imploded during surgery causing the procedure to be delayed.The procedure was a c-section, however the baby had already been delivered.No known issues at this time for the mother.

• Brand Name: CANISTER GUARDIAN 3000CC
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer (Section G): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 7645515
• MDR Text Key: 112870351
• Report Number: 1423537-2018-00215
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00630140152569
• UDI-Public: 00630140152569
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 65651-230
• Device Catalogue Number: 65651-230
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 93