MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 10FR ROUND; CATHETER, IRRIGATION

Model Number 2227

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Paralysis (1997); Not Applicable (3189)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Why does the surgeon believe that the hematoma is related to the drain? why does the surgeon believe that the drain can provide control of bleeding? what was the cause of the hematoma? was there any drain device deficiency noted? attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. .

Event Description

It was reported that during a laminoplasty on (b)(6) 2017, a drain was attached to a reservoir.The drain was placed at the peridural space between t9 and t11.After the procedure, exudate was observed and hematoma had accumulated at the peridural space, and the patient experienced leg paralysis.The patient then underwent a re-operation.Treatment for event is removal of hematoma.According to the surgeon, the situation of the primary operation was as follows: before closing the surgical wound, the surgeon checked condition of hemostasis.At that time, slight venous bleeding was observed.The surgeon thought that the venous bleeding could be controlled by drainage.Then, the surgical wound was closed.The drain was placed vertically, the end of the drain was oriented to the head side.The black dot on the drain was set around the skin.The drain was inserted into a suction device.The pean was placed at the patient¿s armpit.Drainage was continuously performed while closing the surgical wound.When the drain was inserted into the suction device, the surgeon felt that suction was not performed sufficiently.The surgeon felt that flow of blood in the drain was not smooth.The surgeon thought coagulation seen in the surgical field would be the cause of improper suction.Thus, the drain was cleaned.When the drain was almost cleaned up, the surgical wound was closed.At that time, the surgeon still felt that suction was slightly insufficient.The drain was fixed with a suture.However, he suture was not tied firmly.Therefore, it was unlikely that the suture interfered suction.The surgeon opines that there was no causal relationship between the products and the event.

Manufacturer Narrative

Additional information was requested and the following was obtained: was there any alleged deficiency reported against the pds suture and/or dermabond? no.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: why does the surgeon believe that the hematoma is related to the drain? no information.Why does the surgeon believe that the drain can provide control of bleeding? the volume of bleeding was slight.What was the cause of the hematoma? no information.Was there any drain device deficiency noted? no, there wasn't.

Manufacturer Narrative

Actual device returned and evaluated.The broken surface is uneven which shows that the drain possibly broke following some previous cut or nick.There are lots of dry blood clots in the drain which might affect normal drainage process.

Manufacturer Narrative

Pc-000079978 additional narrative: the patient underwent removal of hematoma on (b)(6) 2017, a laminectomy (b)(6) was performed under general anesthesia.Skin incision was about 17cm.No abnormal event occurred during the operation.The drain was placed peridurally.The muscular layer sutured with pds, subcutaneous suture was done with 3-0 pds, and dermabond was used.Reservoir and two suction bags were placed.No abnormality was observed by postoperative x-ray inspection at the area where the drain was placed.The surgeon opined that the paralysis had been caused by the hematoma.After the reoperation, large amount of exudate was observed every day.The total amount of exudate per day was 200 ml at first.Then, it decreased gradually.On (b)(6) 2017, reservoir was removed and on (b)(6) 2017, the suction bags were removed.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/14/2020.

• Brand Name: BLAKE (R) DRAIN 10FR ROUND
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): DEGANIA SILICON LTD.-ISREAL; kibbutz degania bet; emek hayarden ; IS
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082183429
• MDR Report Key: 7120821
• MDR Text Key: 94954191
• Report Number: 2210968-2017-71766
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/11/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 2227
• Device Catalogue Number: 2227
• Device Lot Number: J1702646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 12/20/2017; 12/25/2017; 01/11/2018; 01/21/2018; 08/17/2020
• Supplement Dates FDA Received: 12/21/2017; 01/08/2018; 01/30/2018; 02/14/2018; 09/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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
• Patient Age: 57 YR
• Patient Weight: 58