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

Catalog Number 0043610

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive, as the device was not returned for evaluation.A potential failure mode could be 'loss of vacuum pressure¿ with a potential root cause of 'y connector is not cut to the required size and the drainage tube falls out of the connector.¿ 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: "ensure that the wound site is dry and free of debris before closure.The surgeon must determine the number of drains needed for an effective drainage of the entire wound site.The junction between the tubing and tissue at the drain entrance site must be air-tight for effective functioning of the system.If the drain is occluded, irrigation and/or aspiration of the drain may be required.The quality and quantity of drained fluid must be regularly monitored and reported to the surgeon.Reservoir, once full, must be emptied per hospital protocols.Failure to do so will result in incomplete drainage.Suction must be discontinued prior to the removal of the drain.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: 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.".

Event Description

It was reported that the tubing on the wound drain disconnected after helping the patient back to bed.No medical intervention was reported.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9526150
• MDR Text Key: 176613748
• Report Number: 1018233-2019-08283
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049354
• UDI-Public: (01)00801741049354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0043610
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1