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
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH MALTA 212 LTD; a51, industrial estate; marsa MRS30 00; MT MRS3000
• MDR Report Key: 11598926
• Report Number: 1423537-2021-00618
• Device Sequence Number: 3498113
• Product Code: GCX
• UDI-Device Identifier: 10885380153297
• UDI-Public: 10885380153297
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 65651920
• Device Catalogue Number: 65651920
• Device Lot Number: 20E14
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other