CWS 400ML EVACUATOR KIT WITH 1/8" (3.2MM 10 FR.) 0043660

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-17 for CWS 400ML EVACUATOR KIT WITH 1/8" (3.2MM 10 FR.) 0043660 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[183743236] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bd 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 bd. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[183743237] It was reported that while attempting to remove the drain from the patient's left buttock, the drain tubing broke. The tubing remained inside of the patient. And additional surgery was scheduled for removal.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-01856
MDR Report Key9841630
Report SourceOTHER,USER FACILITY
Date Received2020-03-17
Date of Report2020-04-02
Date Mfgr Received2020-03-23
Device Manufacturer Date2019-05-07
Date Added to Maude2020-03-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCWS 400ML EVACUATOR KIT WITH 1/8" (3.2MM 10 FR.)
Generic NameCWS 400 KIT
Product CodeGCY
Date Received2020-03-17
Catalog Number0043660
Lot NumberNGDQ2620
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-17

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