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

Model Number 2229

Device Problem Leak/Splash (1354)

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

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information received: was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study; unknown, device property of: none, device in possession of: none additional information was requested however not received.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent.Additional information has been requested and received.Attempts have been made to obtain the device but not received to date.If further details are received at a later date a supplemental medwatch will be sent.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? was another drain needed to correct the situation? if yes, was the new drain placed surgically during a second procedure? could you please confirm the product code for the j-vac reservoir? what is the lot number for blake drain and j-vac reservoir? device return status.Note: events reported on mw# 2210968-2022-02115.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 procedure on (b)(6) 2022 and a drain was used.During surgery, the drain is leaking upon installation.No patient consequences reported.

• 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 INDIA; 251, sector-6, imt manesar; gurugram ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13872672
• MDR Text Key: 297243047
• Report Number: 2210968-2022-02114
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003576
• UDI-Public: 10705031003576
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2022

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: 2229
• Device Catalogue Number: 2229
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/24/2022
• 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