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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, PVC DRAIN; WOUND DRAIN
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C.R. BARD, INC. (COVINGTON) -1018233 CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN; WOUND DRAIN Back to Search Results
Catalog Number 0043610
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2019
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 patient was moving from a standing to a sitting position when the surgical drain tubing was accidentally sat on by patient.That caused the tubing to be pulled tight and become severed.The tubing was irreparable as it had become severed in the middle of the line and not at a junction site.An unknown procedure was received to remove the remaining drain tubing from patient.Continued site assessments were made throughout the night to monitor for hematoma.
 
Event Description
It was reported that the patient was moving from a standing to a sitting position when the surgical drain tubing was accidentally sat on by patient.That caused the tubing to be pulled tight and become severed.The tubing was irreparable as it had become severed in the middle of the line and not at a junction site.An unknown procedure was received to remove the remaining drain tubing from patient.Continued site assessments were made throughout the night to monitor for hematoma.
 
Manufacturer Narrative
The reported event was confirmed use-related.The device was not returned for evaluation.The device was being used for treatment at the time of the reported event.A failure mode was 'loss of vacuum pressure.¿ with the root cause of 'tubing/wound drain is damaged.¿ the lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿warnings #10 (c-f) states: 10.To avoid the possibility of drain damage or breakage, please follow these steps: a.Avoid suturing through drains.B.Drains should lie flat and in line with the skin exit areas.C.Particular care should be taken to avoid any obstacles to the drain exit path.D.Drains should be checked for free motion during closure to minimize the possibility of breakage.E.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.F.Surgical removal may be necessary if drain is difficult to remove or breaks." h11:section a through f - 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.H3 other text : the device was not returned.
 
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Brand Name
CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN
Type of Device
WOUND DRAIN
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9526197
MDR Text Key179239483
Report Number1018233-2019-08284
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 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0043610
Was Device Available for Evaluation? No
Date Manufacturer Received01/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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