MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 15FR RND; CATHETER, IRRIGATION

Catalog Number 2228

Device Problem Leak/Splash (1354)

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

Event Date 12/09/2023

Event Type  malfunction  

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2023 and a drain was used."mct bubbling, not draining, removed and hole in tubing found ".No other details provided.Additional information has been requested.

Manufacturer Narrative

Product complaint (b)(4) additional information: h6 component code: g07002 - device not returned additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? how was the case completed? was a new drain needed to be implanted during a secondary procedure? is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.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.

• Brand Name: BLAKE SI DRAIN HBLS 15FR RND
• 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 12205 2; IN 122052
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19176966
• MDR Text Key: 341004825
• Report Number: 2210968-2024-04822
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003569
• UDI-Public: 10705031003569
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2228
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1