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

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.

• 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 Key: 8248609
• MDR Text Key: 133083627
• Report Number: 1018233-2019-00248
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049354
• UDI-Public: (01)00801741049354
• 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: 04/26/2019

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 Date: 09/30/2023
• Device Catalogue Number: 0043610
• Device Lot Number: NGCW1401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention