MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN; CATHETER, IRRIGATION

Catalog Number 2227

Device Problem Leak/Splash (1354)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: did the patient experience an adverse event such as infection, non union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown.Did the patient require revision surgery or hardware removal? unknown.Patient status, outcome, consequences? unknown.Nurse informed that the surgeon was querying as she never had an issue with them for over two decades but lately she's been experiencing.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Unfortunately, the following is not able to be obtained from the customer.1.Please provide lot number.2.If this event occurred in multiple procedures, please provide information requested above for each patient event.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).A) what are the procedure name(s) and date(s)? b) what is the quantity involved per procedure? c) was there any adverse patient consequence(s) or subsequent medical/surgical intervention? no product available for return.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 breast surgery procedure on and unknown date in (b)(6) 2023 and a drain was used.Surgeon experiencing a leak at the site of drain placement.Additional information has been requested.

• Brand Name: BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN
• 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: 18088486
• MDR Text Key: 328598684
• Report Number: 2210968-2023-08622
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2023

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 Catalogue Number: 2227
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/07/2023
• 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