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

Model Number 000451

Device Problems Air Leak (1008); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 during an endoscopic resection of prostate, it was found that the ellik had a leak and air got into the bladder.No medical intervention was reported.

Event Description

It was reported that during an endoscopic resection of prostate, it was found that the ellik had a leak and air got into the bladder.No medical intervention was reported.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "bard® ellik evacuator caution: this product contains natural rubber latex which may cause allergic reactions.Fill with solution.Displace all air before using.This is a single use device.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.Note: for use with resectoscope sheath manufactured by r.Wolf and k.Storz.A separate adapter is enclosed for use with resectoscope sheath manufactured by acmi.Single use do not resterilize caution, consult accompanying documents.Contains or presence of natural rubber latex.Do not use if package is damaged.Units sterilized using ethylene oxide authorized representative in the european community use by catalog number lot number manufacturer caution: federal (usa) law restricts this device to sale by or on the order of a physician.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.".

• Brand Name: BARD® ELLIK EVACUATOR
• Type of Device: ELLIK EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7510293
• MDR Text Key: 108489813
• Report Number: 1018233-2018-01673
• Device Sequence Number: 1
• Product Code: KQT
• UDI-Device Identifier: 00801741080814
• UDI-Public: (01)00801741080814
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 000451
• Device Catalogue Number: 000451
• Device Lot Number: NGBR3049
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1