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 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The following information has been requested and obtained.Attempts to obtain the device have been made.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Was another drain needed to correct the situation? no further information is available.If yes, was a second surgery needed to place the new drain? device return status.We regularly contact with sales rep about the device returning.No further information will be provided.Please advise the issue with the additional product, 2160/reservoir as the reported issue was clearly with the drain: "during an unknown surgery, there was a hole on the middle of the drain, and drained fluid leaked from there" no further information is available.No further information will be provided.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) 2020 and a drain was used.During surgery, there was a hole on the middle of the drain, and drained fluid leaked from the drain outside of the patient¿s body.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 4/28/2021.Additional information: d9, h4.Corrected data: d3.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.H3 evaluation: complaint sample was received from the customer evaluation.The complaint was registered as hole in drain.However the sample received for evaluation was broken in two pieces.It was not possible to corelate with complaint with sample.Hole on drain could not be determined.The complaint sample was received broken in two pieces.On the basis of sample provided it cannot be determined the drain hole in manufacturing process.There was not enough information to determine the root cause.Retain sample of the same lot no.J1920156 were checked visually and found within the specified criteria.There was no hole, damage or crack on the drain 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: 4/28/2021.Corrected data: d3.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: 11016251
• MDR Text Key: 221751294
• Report Number: 2210968-2020-09960
• 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
• Report Date: 12/01/2020

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
• Device Lot Number: J1920156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/28/2021
• Patient Sequence Number: 1