MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CWS 400ML EVACUATOR KIT WITH 1/8" (3.2MM 10 FR.); CWS 400 KIT

Catalog Number 0043660

Device Problem Break (1069)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.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.The device was not returned.

Event Description

It was reported that while attempting to remove the drain from the patient's left buttock, the drain tubing broke.The tubing remained inside of the patient.And additional surgery was scheduled for removal.

Event Description

It was reported that while attempting to remove the drain from the patient's left buttock, the drain tubing broke.The tubing remained inside of the patient.And additional surgery was scheduled for removal.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿loss of vacuum pressure¿ with a potential root cause of "tubing/wound drain is damaged".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: ¿i.Device description: the davol® 400 cws closed wound suction evacuator kits contain wound drains and evacuators.Wound drains are made up of silicone or pvc materials; they are round shaped with perforations.They are packaged with a trocar.400 cc evacuators are made up of pvc materials.Clear evacuator sidewalls with volume calibrations facilitate examination and measurement of drainage fluid.Ii.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.

• Brand Name: CWS 400ML EVACUATOR KIT WITH 1/8" (3.2MM 10 FR.)
• Type of Device: CWS 400 KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9841630
• MDR Text Key: 183743236
• Report Number: 1018233-2020-01856
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049392
• UDI-Public: (01)00801741049392
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

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 Date: 03/31/2024
• Device Catalogue Number: 0043660
• Device Lot Number: NGDQ2620
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention