MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 19FR R/F; CATHETER, IRRIGATION

Model Number 2232

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent date of procedure? no further information is available.Date of event? no further information is available.Were there any anomalies with the drain: appearance, damage or function prior to use? no further information is available.Were there any anomalies with the reservoir: appearance, damage or function prior to use? no further information is available.How was it secured? no further information is available.Was the drain checked for patency during the procedure? no further information is available.Did the drain function as intended? no further information is available.Did the reservoir function as intended? no further information is available.Were any issues noted with the drain during use? the leak was observed on the day of drain removal.When, on what date, was drain removed? six days later.Were there any anomalies with the drain: appearance, damage or function after removal? no further information is available.On what date was 2nd drain placed? no further information is available.Was there any issues with 2nd drain? no further information is available.Why were a quantity of 2 drains reported with the complaint? no further information is available.Lot number of drain? no further information is available.Patient¿s current status? the patient is currently under follow-up, and the course is good.What is the surgeon¿s opinion of the impact of the drain on the patient consequences? the doctor thinks that it may be a problem of negative pressure or way of placement.The leak was observed on the day of drain removal.Drain was removed at 9 o'clock am, and the patient complained of abdominal pain around 10 o'clock am.Thereafter, ct confirmed a leak.Reoperation was performed, and an emergency stoma was created.At present, a drain is placed with natural pressure without applying negative pressure.The patient is currently under follow-up, and the course is good.The patient's condition will be checked again in 3 months.

Event Description

It was reported a patient underwent a colorectal resection surgery on an unknown date and a drain was used.Drain was placed at anastomotic site.Six days later, after confirming that there was no problem such as a leak and the drain was removed, a leak occurred from the anastomotic site.The doctor opined that it may be a problem of negative pressure or way of placement.Further details are not provided.No sample will be returned.

• Brand Name: BLAKE (R) DRAIN 19FR R/F
• 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: 12264270
• MDR Text Key: 264972331
• Report Number: 2210968-2021-06901
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: 10705031003606
• 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: 07/07/2021

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 Model Number: 2232
• Device Catalogue Number: 2232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/02/2021
• 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
• Patient Outcome(s): Required Intervention