MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN HBLS 15 FR; CATHETER, IRRIGATION

Model Number 2233

Device Problem Leak/Splash (1354)

Patient Problem Necrosis (1971)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: component code: (b)(4) device not returned.Additional information received: when it was consulted with a dermatologist about the cause of flap necrosis, the doctor said, "more intense suctioning is better".Because the suction pressure of j-vac is low, change to sb vac with high suction pressure.Other contributing factor]: a possibility that the drain was damaged by some operation and air leaked.Misoperation of reservoir.The following information has been requested however not received.If the further details are received at a later date a supplemental medwatch will be sent.What is the lot number of the drain? what is the lot number of the reservoir? can you please clarify if leakage from the drain was observed? was there any medical or surgical intervention performed to treat the flap necrosis (re-operation; prescription steroids; antibiotics prescribed; other medication prescribed)? if so, please clarify.Was another drain needed to correct the situation? if yes, was the new drain placed surgically during a second procedure? was another drain needed to correct the situation? no product to be returned.Note: events reported on mw# 2210968-2021-04755.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a mastectomy procedure on (b)(6) 2021 and a drain was used.During the mastectomy, flap necrosis occurred, dermatology follow up.Further details are not provided.No sample will be returned.Additional information has been requested.

• Brand Name: BLAKE (R) DRAIN HBLS 15 FR
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA SILICON LTD.-ISREAL; degania bet; emek hayarden 15130 ; IS 15130
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11843959
• MDR Text Key: 251420090
• Report Number: 2210968-2021-04754
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003613
• UDI-Public: 10705031003613
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2233
• Device Catalogue Number: 2233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1