MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 19FR R/F; CATHETER, IRRIGATION

Model Number 2230

Device Problem Leak/Splash (1354)

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

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been 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.Did the drain and reservoir come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? was the new drain placed surgically during a second procedure? device return status: note: events reported on mw# 2210968-2021-10758.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 (b)(6) 2021 and drain was used.During surgery, drain was perforated.Another product that was in stock was used.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h4 the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h3 evaluation: product received for analysis.One used sample of damaged drain was received for evaluation, size 10 mm (actual size of drain 1200 ±15 mm).On inspection of drain sample, hole found on the drain wihich seems to be done with sharp object.Complete drain sample not received for evaluation.Performing 100% visual inspection before release of product.So this defect can not be generated during our manufacturing process.Retain samples were checked for lot # j2006590 and no defect related to complaint was observed.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 (R) DRAIN 19FR R/F
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA SILICON LTD.-INDIA; 251, sector-6; imt manesar; gurgaon 12205 0; IN 122050
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12740862
• MDR Text Key: 279697025
• Report Number: 2210968-2021-10759
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2022

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: 2230
• Device Catalogue Number: 2230
• Device Lot Number: J2006590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 11/17/2021; 04/22/2022
• Supplement Dates FDA Received: 11/29/2021; 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1