MAUDE Adverse Event Report: CARDINAL HEALTH MALTA 212 LTD MEDI-VAC FLEX ADVANTAGE - 1500 ML; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651920

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing device history record for the referenced lot number 20e14 was completed.Product was manufactured on the 19th may 2020.No non-conformance with regards to ¿fluid leak¿ was noted during the manufacture of this batch.The investigation determined that all products were manufactured, inspected, and released in accordance with our established specification for quality and efficacy.No sample was received; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.It was reported the fluid leaked from the red braided tube, (the connection between the flex advantage liner and the hard canister) while health care profession was deactivating the system.As a result, fluid hit the hcp in one eye.This a common occurrence when one is detaching the liner from the hard canister.The sound is caused when the flex advantage lid ridges comes off the hard canister.It was also reported that the both the hard canister and flex advantage remained intact and not parts where broken.Based on this information and the lack of sample, one cannot identify the location from where the leak had occurred, so the root cause would be unknown.Without a specific assignable cause, no specific corrective actions are deemed applicable, 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 Description

During the substitution of the device, in particular while operator was deactivating the vacuum removing the red tube, the biological liquid which was collected in the device, came out from the red tube and hit the health care professional in one eye.The hcp was then monitored to identify the health status and tested for possible infections.On top of that, inail was informed (submitter's comment: inail is the national authority which monitors injury on the working place).

• Brand Name: MEDI-VAC FLEX ADVANTAGE - 1500 ML
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH MALTA 212 LTD; a51, industrial estate; marsa MRS30 00; MT MRS3000
• Manufacturer (Section G): CARDINAL HEALTH MALTA 212 LTD; a51, industrial estate; marsa MRS30 00; MT MRS3000
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 11598926
• MDR Text Key: 243328074
• Report Number: 1423537-2021-00618
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10885380153297
• UDI-Public: 10885380153297
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 65651920
• Device Catalogue Number: 65651920
• Device Lot Number: 20E14
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other