MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® ELLIK BLADDER EVACUATOR

Model Number 0450M

Device Problem Fitting Problem (2183)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the metal piece did not fit into the latex tube.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿cleaning and sterilization instructions: prior to cleaning: prior to initial cleaning and sterilization, remove all packaging.The latex tubing should be replaced after ten (10) sterilization cycles.Monitor the number of uses checking for sticking or cracking of the latex tubing.Use personal protective equipment (e.G.Gloves, gowns, eyewear, face mask or shields, respiratory protection devices).Appropriately to protect users from exposure to both chemicals and microorganisms.After use, devices may be a potential biohazard.Handle in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Between uses the device should be cleaned with an automated cleaning method, visually examined, and sterilized per the instructions below.Automated cleaning: timing ¿ clean medical devices as soon as practical after use (e.G.At the point of use) because soiled materials become dried onto the instruments.Dried or baked materials on the instrument can make the removal process more difficult.Point of use pre-cleaning ¿ remove excess soil with a liquid flush with cool potable tap water (maximum 25°c, 77°f).Allow the water to drain from the device.Automated cleaning ¿ - cleaning solution - prepare, use, and rinse with an enzymatic detergent solution according to manufacturer¿s instructions.Enzol¿ or cidezyme¿ enzymatic detergent was validated with these devices using 1oz per gallon of warm tap water 27°c to 44°c (81°f to 111°f).If using an equivalent enzymatic detergent solution, refer to manufacturer¿s instructions for dilution and water temperatures.Water temperature should not exceed 45°c (113°f) for any step of this cleaning process.Presoak - completely immerse the device in the enzymatic detergent solution for a minimum of one (1) minute.Allow the detergent solution to fill all components by manipulating the device.After soaking, drain the detergent solution from device.Disassembly - disassemble the device by removing the latex tubing, metal connector, and rubber bulb.Brush - use a clean, soft bristle brush to clean all internal and external surfaces.Brush each component for a minimum of one (1) minute.The brush should be an appropriate size to reach all internal surfaces and lumens.Flush each component with a minimum of 50 ml of detergent solution with a syringe of appropriate size.Repeat the flush process nine (9) times for a total of ten (10), ensuring all fluid exiting the components is clear of gross soil.If visible soil is detected during the final flush, repeat brushing and flushing steps.Rinsing ¿ rinse the device thoroughly under warm running tap water with a temperature range of 27°c to 44°c (81°f to 111°f), for a minimum of one (1) minute to remove any residual detergent or debris.Use a syringe of an appropriate size to flush hard to reach places.Flush each component with a minimum of 50 ml of warm tap water (27°c to 44°c, 81°f to 111°f).Repeat the rinsing process twice for a total of three (3) times per component.Washer-disinfector ¿ follow automatic washer manufacturer¿s instructions for maximum load characteristics." correction: concomitant medical products, device evaluated by mfr.

Event Description

It was reported that the metal piece did not fit into the latex tube.

• Brand Name: BARD® ELLIK BLADDER EVACUATOR
• Type of Device: BLADDER EVAC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8596787
• MDR Text Key: 144805433
• Report Number: 1018233-2019-02409
• Device Sequence Number: 1
• Product Code: KQT
• UDI-Device Identifier: 00801741080807
• UDI-Public: (01)00801741080807
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0450M
• Device Catalogue Number: 0450M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1