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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CWS 400 CLOSED WOUND SUCTION KIT; CLOSED WOUND SUCTION DRAIN

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C.R. BARD, INC. (COVINGTON) -1018233 CWS 400 CLOSED WOUND SUCTION KIT; CLOSED WOUND SUCTION DRAIN Back to Search Results
Catalog Number 0043610
Device Problem Break (1069)
Patient Problems Fever (1858); Foreign Body In Patient (2687); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the closed wound drain broke inside of patient.The patient had a lumbar 3-5 revision of posterior spinal fusion and lumbar 5-sacral 1 anterior lumbar interbody fusion, which required a closed wound drain.Post surgery, the patient developed a fever and an increase in white blood cell count.Two days post op while attempting to remove the wound drain via hemovac the drain broke.The following day the patient required surgery for removal of the broken drain piece and wound revision.
 
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 were found adequate and state the following: "10 to avoid the possibility of drain damage or breakage, please follow these steps: avoid suturing through drains.Drains should lie flat and in line with the skin exit areas.Particular care should be taken to avoid any obstacles to the drain exit path.Drains should be checked for free motion during closure to minimize the possibility of breakage.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments as these could cause cuts or nicks and lead to subsequent structural failure of the drain.Surgical removal may be necessary if drain is difficult to remove or breaks.This is a single use device.Do not reuse.Do not re-sterilize.Trocar and evacuator are mr unsafe." the device was not returned.
 
Event Description
It was reported that the closed wound drain broke inside of patient.The patient had a lumbar 3-5 revision of posterior spinal fusion and lumbar 5-sacral 1 anterior lumbar interbody fusion, which required a closed wound drain.Post surgery, the patient developed a fever and an increase in white blood cell count.Two days post op while attempting to remove the wound drain via hemovac the drain broke.The following day the patient required surgery for removal of the broken drain piece and wound revision.
 
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Brand Name
CWS 400 CLOSED WOUND SUCTION KIT
Type of Device
CLOSED WOUND SUCTION DRAIN
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8248609
MDR Text Key133083627
Report Number1018233-2019-00248
Device Sequence Number1
Product Code GCY
UDI-Device Identifier00801741049354
UDI-Public(01)00801741049354
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2023
Device Catalogue Number0043610
Device Lot NumberNGCW1401
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/26/2018
Initial Date FDA Received01/15/2019
Supplement Dates Manufacturer Received04/03/2019
Supplement Dates FDA Received04/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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