MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT CANNISTER SUCTION 1500CC FLEX; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65652-616

Device Problem Suction Failure (4039)

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

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

This is an ongoing investigation involving quality, production, engineering, marketing, sales and the customer.There is a continuation of complaints from this customer on 1500cc flex¿ canister w/valve exhibited damage to the on/off valve.A review of the manufacturing device history record for the referenced lot number was conducted.This investigation determined that all products were manufactured, inspected, and released in accordance with our established specifications for quality and efficacy.Samples were provided by the customer, and a visual examination was completed by engineering, quality and production personnel regarding the breakage of the hardware components.The breakage is visible, and the team believes it is due to the use of contraindicated cleaners, which would weaken the polycarbonate material.The current ifu states cleaning processes allowed.Additionally, our polycarbonate vendor literature also does not recommend the use of polycarbonate material with benzene (phenols) stating that these solvents will cause crazing or cracking.It is cardinal health's position that repeated chlorinated hydrocarbon solvent cleaning might cause the polycarbonate material to relieve internal stress.Chlorinated benzene-based hydrocarbon germicidal / cleaning / disinfecting products per manufacturer's literature, or other harsh solvents are not recommended to be used on the polycarbonate hard canister system.These cleaning agent's literature further states that this is a cleaner for "hard surfaces only".The polycarbonate material that is utilized for our hardware items does not represent a non-porous surface.Per marketing evaluation, the medi-vac® suction outer canisters and ancillary roll stands, and holders should be cleaned with warm soapy water, ethanol, isopropanol, or bleach (naoci).Normally the frequency of the cleaning is dictated by the hospital policy.Based on the information provided by the customer, and the ongoing discussions the manufacturing personnel have with the cardinal health sales team assigned this customer, the assignable cause at this time is customer misuse.Corrective action currently includes discussions of a customer visit by engineering and/or quality representatives from the site.Trending for the past 3 calendar years, indicates these sole customer multiple complaints are the first complaints of on/off valve breakage to part number 65651-616.

Event Description

Customer reported broken canister with a loss of suction before emergency c-section surgery.Another device was obtained to finish the procedure.There was a 5-minute delay with no injury or adverse event to the patient.No patient demographics were provided when requested.

• Brand Name: CANNISTER SUCTION 1500CC FLEX
• 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 dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 11508020
• MDR Text Key: 240582955
• Report Number: 1423537-2021-00609
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10630140153860
• UDI-Public: 10630140153860
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 65652-616
• Device Catalogue Number: 65652-616
• Device Lot Number: 281078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other