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

Model Number 2233

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information has been requested and obtained.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent what is the lot number? no further information is available.How was the case completed? no further information is available.Was another drain needed to correct the situation? no further information is available.If yes, was the new drain placed surgically during a second procedure? device return status.We regularly contact with sales rep about the device returning.No further information will be provided.Qty to be returned: 0.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 an unknown surgery on an unknown date and a drain was used.Post op, an air leak was confirmed in the ward.Further details are not provided.There were no adverse consequences to the patient.

• 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: 12159976
• MDR Text Key: 261348227
• Report Number: 2210968-2021-06263
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/13/2021
• 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