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

Model Number 2229

Device Problem Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

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.Can you identify the lot number of the product that was used? no.What was done to treat the surgeon's injury? registered nurse ¿ who would have had to have bloods taken, and first aid treatment attended to.Was medical or surgical intervention required? yes.Was there any special diagnostic test performed? initial bloods taken and then the staff member will need to come in and have addition bloods taken to confirm that they haven¿t acquired hiv, hep c etc.What is the status of the surgeon injury today? she is fine.Did the issue occurred during surgery? yes.If so, were there any patient consequences? no.

Event Description

It was reported a patient underwent an unknown procedure on an unknown date in 2021 and a drain was used.The nurse attempted to remove the plastic protective sheath from the drain.The sheath was tight that when it came off, hands flicked back together and the trocar cut through both gloves and stabbed into nurse's little finger.First aid to address finger.Initial bloods taken.Additional information has been requested.

• Brand Name: BLAKE (R) DRAIN 15FR 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: 11741427
• MDR Text Key: 250955588
• Report Number: 2210968-2021-03951
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003576
• UDI-Public: 10705031003576
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2229
• Device Catalogue Number: 2229
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2021
• 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