CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN 0043610

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 2020-02-18 for CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN 0043610 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[183949452] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[183949453] It was reported that the drain pulled apart at the "y" connection. The complainant noted that the drain did not keep pressure for suction. The writer attempted to reseat and make sure all connections on the drain and at the y connector were hooked in correctly. Several attempts reportedly failed. The nurse reportedly looked at the site where the drain tubing entered the patient's back, and a "hissing" noise could be heard when attempting to depress the drain. They were unable to see any damage to the tubing. The suture remained intact, and did not appear to be pulled out at the time. The nurse was reportedly advised to pull the drain. The drain was reportedly in use for 16 hours.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-01102
MDR Report Key9722529
Report SourceOTHER,USER FACILITY
Date Received2020-02-18
Date of Report2020-03-23
Date of Event2020-01-25
Date Mfgr Received2020-03-19
Date Added to Maude2020-02-18
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 400 CLOSED WOUND SUCTION KIT, PVC DRAIN
Generic NameWOUND DRAIN
Product CodeGCY
Date Received2020-02-18
Returned To Mfg2020-02-05
Catalog Number0043610
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-18

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