MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 15FR R/F; CATHETER, IRRIGATION

Model Number 2229

Device Problem Leak/Splash (1354)

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

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Additional information was requested however and was received.To date the product has not been received.If further details are received at a later date a supplemental medwatch will be sent.Please confirm, was the drain placed in the patient? yes.Was leakage detected when activating? yes.How was the issue noticed? leakage detected when activated.How was the case completed? used another drain.Was the damaged drain removed surgically? no.Was a new drain needed to be implanted during a second surgery? no.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 abdominoplasty on (b)(6) 2021 and a drain was used.The drain tubing was stuck or melted to the side of the trocar.The drain placed in the patient.A leakage was detected when activating.When the surgeon attempted to pull the two apart, in created a small hole in the silicone tubing rendering it unusable.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 3/3/2021.Additional information: h6 component code: g07002 device not returned.H3 evaluation: complaint sample was not received to date for evaluation.Retain sample of the same lot no.Were checked visually and found within the specified criteria.There was no stickiness observed between trocar needle and drain.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: 4/14/2021.Additional information: d9.Corrected data: d3.H3 evaluation: complaint sample was received.During evaluation of complaint sample, adhesion marks of drain were observed on the trocar and small hole on the drain.Complaint is verified the actions have been documented in dmd capa 2/20.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: 4/14/2021.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 15FR R/F
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11311493
• MDR Text Key: 234263647
• Report Number: 2210968-2021-01290
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003576
• UDI-Public: 10705031003576
• 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: 01/21/2021

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: 2229
• Device Catalogue Number: 2229
• Device Lot Number: J1922085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/15/2021; 03/26/2021
• Supplement Dates FDA Received: 03/03/2021; 04/14/2021
• Patient Sequence Number: 1