MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that the ethicon product (blake drain) caused and/or contributed to the mortalities described in the article? please confirm what specific event and number of patients which lead to the 90-d mortality or mortality of patients, and if this is a direct result of the use of the blake drain (ethicon).Does the surgeon believe that the ethicon product (blake drain) caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product (blake drain) used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Would the surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the product involved in this event? patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Note: events reported on mw# 2210968-2021-03066.Citation: j am coll surg.May 2020; vol.230 (5): 809-818.Doi: https://doi.Org/10.1016/j.Jamcollsurg.2020.01.028.

Event Description

Title: extended experience with a dynamic, data-driven selective drain management protocol in pancreaticoduodenectomy: progressive risk stratification for better practice authors: maxwell t trudeau, bs, laura maggino, md, bofeng chen, ba, matthew t mcmillan, major k lee, md, phd, robert roses, md, ronald dematteo, md, facs, jeffrey a drebin, md, phd, facs, charles m vollmer jr, md, facs citation: j am coll surg.May 2020; vol.230 (5): 809-818.Doi: https://doi.Org/10.1016/j.Jamcollsurg.2020.01.028.The aim of this extended, single-center experience study was to assess the outcomes of progressive risk stratification, which occurs through a dynamic modular process spanning the intra- and postoperative periods.Another objective was to assess individual surgeons¿ performance in reference to their adherence to this protocol.Between july 2014 and february 2019, a total of 400 patients (female=199) who underwent pancreaticoduodenectomies (pds) were included in the study.Drain use consisted of a single no.19 blake drain (ethicon) placed in front of both the biliary and pancreatic anastomoses-placed to either suction or passive drainage thereafter.The drain was placed in negligible/low-risk frs patients (n=41) who were considered "off protocol" and in moderate/high-risk frs patients (n=282) considered as "on-protocol".Reported complications included clinically relevant postoperative pancreatic fistula (cr-popf; n=34), chyle leak (n=?), any complication (n=?), severe complication (n=?), sepsis (n=?), unknown events (n=?) which requires icu transfer in 34 patients, antibiotic use in 141 patients, tpn or ten use in 80 patients, postoperative transfusion in 47 patients, percutaneous drainage in 29 patients, reoperation in 15 patients, 90-d readmission in 75 patients, and unknown event (n=?) leading to 90-d mortality or mortality in 3 patients.In conclusion, this extended experience validates a dynamic drain management protocol, providing a model for better drain management and individualized patient care after pancreaticoduodenectomy.This study confirms that drains can be safely omitted from negligible/low-risk patients, and moderate/high-risk patients benefit from early drain removal.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA SILICON LTD.-ISREAL; degania bet; emek hayarden 15130 ; IS 15130
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11625294
• MDR Text Key: 260985052
• Report Number: 2210968-2021-03065
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention