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

Model Number 2217

Device Problem Leak/Splash (1354)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Health effect clinical code: pneumoperitoneum.Additional information has been requested however not received.Attempts to obtain the device have been made but to date has not been received.If further details are received at a later date a supplemental medwatch will be sent.How long in minutes was the surgery lengthened? date of procedure? name of laparascopic procedure? was there any damage noted to the drain prior to use? any damage after removed? did drain come into contact with any sharp devices or cautery? was there any change in the patient¿s post-operative care due to the prolonged procedure? was an ethicon j-vac reservoir used to activate drainage? if so, were the any quality issues associated to the reservoir? device return status.Note: events reported on mw# 2210968-2021-02612, mw# 2210968-2021-02614.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 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: 4/19/2021.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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? name of laparascopic procedure? was there any damage noted to the drain prior to use? any damage after removed? did drain come into contact with any sharp devices or cautery? was there any change in the patient¿s post-operative care due to the prolonged procedure? 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? 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: 4/19/2021 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.

Manufacturer Narrative

Product complaint # : (b)(4).Date sent to the fda: 7/21/2021.H3 evaluation: all three lots complaint samples were received for evaluation.All three samples were in one pouch.At the time of evaluation of complaint sample, only two drains and three trocars were found.However, three trocars and three drains should be provided.Drains were in two pieces and it was not possible to identify the area from where the drains were leak.Retain sample of the same lot no, were checked visually and found within the specified criteria.There was no leak observed from drain.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 08876
• MDR Report Key: 11546326
• MDR Text Key: 241844919
• Report Number: 2210968-2021-02613
• 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,Followup,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• 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
• Device Lot Number: J2015666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Date Manufacturer Received: 07/22/2021
• Patient Sequence Number: 1