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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
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C.R. BARD, INC. (COVINGTON) -1018233 CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN Back to Search Results
Model Number 0043610
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2021
Event Type  malfunction  
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 customer had lot of issues with disconnections post operatively on the floor.The issue was related with the tube from the drain getting disconnected from the larger tube that connects to the canister.Customer concerned about possible infection risks based on the disconnections.As per additional information, it was reported that the tubing was kinking.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "loss of vacuum pressure".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: indications for use: wound drains are used to remove exudates from wound sites.Iii.Contraindications: do not use for chest drainage.Iv.Precautions: 1.Ensure that the wound site is dry and free of debris before closure.2.The surgeon must determine the number of drains needed for an effective drainage of the entire wound site.3.The junction between the tubing and tissue at the drain entrance site must be air-tight for effective functioning of the system.4.If the drain is occluded, irrigation and/or aspiration of the drain may be required.5.The quality and quantity of drained fluid must be regularly monitored and reported to the surgeon.6.Reservoir, once full, must be emptied per hospital protocols.Failure to do so will result.In incomplete drainage.7.Suction must be discontinued prior to the removal of the drain.8.Before starting the drainage procedure, ensure that all the connections are tight and free of any obstructions within the drainage pathway.Connections to check are: i) drain to suction source.Ii) y-connector (when applicable): ¿ drain to y-connector.¿ y-connector to suction source.9.Di(2-ethylhexyl) phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks." 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.
 
Event Description
It was reported that the customer had lot of issues with disconnections post operatively on the floor.The issue was related with the tube from the drain getting disconnected from the larger tube that connects to the canister.Customer concerned about possible infection risks based on the disconnections.As per additional information, it was reported that the tubing was kinking.
 
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Brand Name
CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN
Type of Device
CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11996899
MDR Text Key256167536
Report Number1018233-2021-03496
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 health professional,other,use
Type of Report Initial,Followup
Report Date 09/07/2021
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 Model Number0043610
Device Catalogue Number0043610
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/20/2021
Initial Date FDA Received06/14/2021
Supplement Dates Manufacturer Received09/07/2021
Supplement Dates FDA Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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