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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 BARD® ELLIK EVACUATOR Back to Search Results
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.".
 
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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 Key7510293
MDR Text Key108489813
Report Number1018233-2018-01673
Device Sequence Number1
Product Code KQT
UDI-Device Identifier00801741080814
UDI-Public(01)00801741080814
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Date04/30/2022
Device Model Number000451
Device Catalogue Number000451
Device Lot NumberNGBR3049
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/26/2018
Initial Date FDA Received05/14/2018
Supplement Dates Manufacturer Received05/31/2018
Supplement Dates FDA Received06/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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