MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT 1000CC FLEX CANISTER; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65652-611
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.However, one picture was received from the customer for evaluation.A visual examination of the picture was completed with production, engineering, and quality management.The picture depicted a patient room in which the outer canister (65652-611) with a flexible liner (65651910) was set up directly on the floor with tubing attached to a vacuum regulator toward the ceiling.Per the directions for use, if not already in a mounting bracket, place reusable hard canister into bracket on a roll stand or wall mount.If the canister and liner was directly on the floor during use, this may increase the risk of suction being delayed; however, without the actual event sample involved in the customer incident and duplication of the non-conformance, no specific assignable cause can be determined regarding the reported incident.Without a specific assignable cause, no specific corrective actions can be completed; however, we will continue to monitor concerns such as these for possible future actions.Key production and quality personnel have been made aware of this reported incident through the investigation process.
Event or Problem Description
A (b)(6) patient was treated for an idiopathic thoracolumbar scoliosis of adolescence.In post-surgery, during a gastric aspiration a medi-vac suction system, connected to ch12 nasogastric probe (fitting bucket) was used.Several suction sets and several regulators (depression rate: from 0 to -200 mbar) were used by the nurses before obtaining the aspiration.Clinical consequences: procedure delayed.Practitioner performed a manual aspiration using a syringe.Healthcare professionals were doubtful on their ability to achieve a rapid and effective aspiration in an emergency situation.Measures: the defective canisters were discarded.Despite the previous medi-vac system information of use to personal, the intended use is still unknown (no canister fixation, no reinforced tubing from vacuum source to the canister).

• Brand Name: 1000CC FLEX CANISTER
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 7666814
• Report Number: 1423537-2018-00219
• Device Sequence Number: 1370195
• Product Code: GCX
• UDI-Device Identifier: 10885380042638
• UDI-Public: 10885380042638
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 65652-611
• Device Catalogue Number: 65652-611
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention