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

Model Number 2227

Device Problem Leak/Splash (1354)

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

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Please provide lot number: unk.The event description suggests the drain was found broken, but the impacted product reported is a jvac reservoir.Please clarify where was leakage detected, blake drain or jvac reservoir (please choose one)?: no further information is available."can you please identify the product code and lot number of the blake drain used?" no further information is available."was the drain broken into two or more pieces?" no further information is available.Status of product return: the device has been received at sukagawa and will be shipped.Please check rmao.No further information will be provided.Note: events reported mw# 2210968-2022-04280.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 a laminoplasty on (b)(6) 2022 and a drain was used.In the ward, there was liquid leak from the drain during use and it was suspected to be broken, but the broken location could not be identified.The product was used on subcutaneous.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6.Component code.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).Product sample returned for analysis.Drain sample was received in two pieces of 650mm and 290mm, actual size of drain dispatched was 1200mm.The trocar had been cut of from the drain and a cut mark was observed near the tip which is likely to happen due to sharp object used during surgery, thereby external factors like improper handling, improper usuage at user end could not be ruled out.Further investigation of the sample was not possible.Lot number unknown, retain sample could not be checked.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 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 ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14596653
• MDR Text Key: 301849568
• Report Number: 2210968-2022-04281
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 08/15/2022

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 Model Number: 2227
• Device Catalogue Number: 2227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/15/2022; 08/10/2022
• Supplement Dates FDA Received: 08/04/2022; 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1