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

Model Number 004501

Device Problems Fracture (1260); Material Split, Cut or Torn (4008)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

It was reported that the customer seemed to be experiencing some issues with the ellik evacuator cracking open during use.The ones they recently purchased were to replace some that were doing this.However, one of the new ones also split yesterday.They are just trying to troubleshoot what could be causing this.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "bulb or connecting joint is damaged, bulb not to specification, pin-hole crack in bulb".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." h11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the customer seemed to be experiencing some issues with the ellik evacuator cracking open during use.The ones they recently purchased were to replace some that were doing this.However, one of the new ones also split yesterday.They are just trying to troubleshoot what could be causing this.Per additional information received on 23aug2022, stated that they did not know exactly how long the device had been in use or how many uses, however they did know that it was one of the newer ones they had purchased.No medical intervention was needed for the patient.Stated that the operating room had 4 other bulbs that appeared to be newer that had also done the same thing within a month's timeframe.Customer just wanted to figure out the underlying cause of why that was happening to prevent having to continue purchasing replacements.

• Brand Name: ELLIK BLADDER EVACUATOR
• Type of Device: ELLIK EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15283171
• MDR Text Key: 305354256
• Report Number: 1018233-2022-06637
• Device Sequence Number: 1
• Product Code: KQT
• UDI-Device Identifier: 00801741049057
• UDI-Public: (01)00801741049057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 004501
• Device Catalogue Number: 004501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other