MAUDE Adverse Event Report: ETHICON INC. BLAKE 10MM FLAT 3/4; CATHETER, IRRIGATION

Model Number 2217

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested and was obtained.If further details are received at a later date a supplemental medwatch will be sent.How long in minutes was the surgery lengthened? 45 minutes minimum.Date of procedure? unk.Name of laparoscopic procedure? unk.Was there any damage noted to the drain prior to use? unk.Any damage after removed? unk.Did drain come into contact with any sharp devices or cautery? unk.Was there any change in the patient¿s post-operative care due to the prolonged procedure? unk.Was an ethicon j-vac reservoir used to activate drainage? use of 6 reservoirs because no vacuum.If so, were the any quality issues associated to the reservoir? unk.

Event Description

It was reported a patient underwent an unknown laparoscopic procedure on an unknown date in 2021 and a drain was used.At the end of surgery, the drain leaked and does not keep the receptacle vacuum.Drain changed.Surgery time was lengthened.Resumption of the laparoscopic route twice with reinsufflation, cooling of the patient, increased pain in the patient at the level of the drain opening and consequence of a prolonged pneumoperitoneum.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 7/21/2021.Additional information: h6 component code: g07002 device not returned.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 10MM FLAT 3/4
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11852907
• MDR Text Key: 269040185
• Report Number: 2210968-2021-04785
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003538
• UDI-Public: 10705031003538
• 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: 04/23/2021

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: 2217
• Device Catalogue Number: 2217
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 07/21/2021
• Patient Sequence Number: 1