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

Model Number 2227

Device Problem Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent what is the lot number? no further information is available.Was the second drain placed during the same procedure? no further information is available.Or was the new drain placed surgically during a second procedure? no further information is available.Were there any patient consequences as a result of the new drain placement? if so, was there any associated medical or surgical intervention? no further information is available.Device return status: we regularly contact with sales rep about the device returning.No further information will be provided.The customer regarded the drain and reservoir as ¿one drainage system.¿ thus, it regarded this issue as an ¿issue with the system.¿ therefore, it returned the both of the drain and reservoir.Therefore, we would like you to investigate both of them.Note: events reported on mw# 2210968-2021-02921.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 spinal surgery on an unknown date a drain was used.The drain was inserted to the epidural space, and the patient was moved from the prone position to the supine position upon leaving operation room, it was noticed that drainage was not done.The drain was replaced, and the condition improved.When the drain was checked, damage/holes were found around the area fixed with silk.An additional incision was made when the drain was reinserted.Thereafter, the patient's condition is normal.Further details are not provided.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 6/2/2021.H3 evaluation: complaint sample was received for evaluation.After opening the complaint sample primary pack, it was observed that there was a small piece of drain.The complaint sample (drain) was not in original its length.The size of complaint drain was 300mm while the complete drain is 1200mm.On the basis of sample receive, there are no enough evidences to evaluate the complaint.Evaluation of retain sample was not done as the lot number is not specified.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: 5/5/2021.Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent.Name of spinal procedure? no further information is available.Date of spine procedure? no further information is available.Date of removal, replacement of new drain? no further information is available.It was noted an incision was made to place a new drain? please describe? an additional incision was made when the new drain was inserted.Were there any anomalies with the drain: appearance, damage or function? damage and hole(s) were found at a part on the drain where the drain was fixed using a silk.How was the drain secured? no further information is available.Was the drain checked for patency during the procedure? no further information is available.Did the drain function as intended? when moving the patient from the operation room, the body direction of the patient was changed from ""prone"" (facing down) to ""supine"" (facing up.) at that time, it was noticed that drainage was not done.Were any issues noted with the drain during use? when moving the patient from the operation room, the body direction of the patient was changed from ""prone"" (facing down) to ""supine"" (facing up.) at that time, it was noticed that drainage was not done.What is the surgeon¿s opinion of the impact of the drain on the patient consequences? no further information is available.Patient¿s current status? no further information is available.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.Product complaint #: (b)(4).Date sent to the fda: 5/5/2021.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 08876
• MDR Report Key: 11596883
• MDR Text Key: 244290925
• Report Number: 2210968-2021-02920
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/01/2021
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/08/2021; 05/26/2021
• Supplement Dates FDA Received: 05/05/2021; 06/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention