MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 10FR ROUND; CATHETER, IRRIGATION

Model Number 2227

Device Problem Leak/Splash (1354)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information has been requested and obtained.Attempts to obtain the device however not received.What is the lot number? no further information is available.Was there any change in the patient¿s post-operative care due to the prolonged procedure? no further information is available.Device return status; we regularly contact with sales rep about the device returning.No further information will be provided.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent please clarify timing of event.The event description states that it occurred during surgery or "intra-op" on (b)(6) 2021, but the date of the "event displays (b)(6) 2021.

Event Description

It was reported a patient underwent a spinal fusion surgery on (b)(6) 2021 and a drain was used.During surgery, after the drain was placed subcutaneously and the wound was closed, when starting suction, air leak occurred at a little above the black mark point.It seemed that there was a hole, and it was fixed with a adhesive but the drain was removed just in case, and another new drain was re-inserted.It was commented that it wasn¿t damaged by the needle, and there may have been a hole from the beginning.The operation time was extended within 30 minutes.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/7/2021.H3 evaluation: after opening the primary pack, one sample of used drain was received for evaluation.There was tape tied up on the drain along with the black thread.Visual inspection of the complaint sample was done but no hole, cut marks or scratch was found on the complete length of drain sample also near to black dot mark.Tape and thread was opened, and leak test was performed but there was no leak observed.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).Date sent to the fda: 8/9/2021.Additional information has been requested and received.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent.Please clarify timing of event.The event description states that it occurred during surgery or ""intra-op"" on (b)(6) 2021, but the date of the ""event displays (b)(6) 2021.The sales rep reported that the procedure date is (b)(6) 2021, and the event date is (b)(6) 2021.However, according to the reported content, the event date seemed to be the same day as the procedure date.No further information will be provided." 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 10FR ROUND
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12158054
• MDR Text Key: 261214867
• Report Number: 2210968-2021-06256
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2021

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: 2227
• Device Catalogue Number: 2227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 07/13/2021; 08/11/2021
• Supplement Dates FDA Received: 08/09/2021; 09/08/2021
• Patient Sequence Number: 1