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); Hemorrhage/Bleeding (1888)

Event Date 02/28/2021

Event Type  Death  

Manufacturer Narrative

(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 author/surgeon believe that ethicon product: blake drain involved caused and/or contributed to death (postoperative mortality )? does the author/surgeon believe that ethicon: blake drain involved caused and/or contributed to non-death cases with post-op complications: postoperative pancreatic fistula, postpancreatectomy haemorrhage, overall morbidity, severe morbidity/clavien-dindo =iiib described in the article? please specify.Does the author/surgeon believe there was any deficiency with the ethicon: blake drain, used for all cases in this study? if yes, please provide patient demographics for each of the death case and non-death cases with post-op complications (clavien-dindo > iiib, fistula and hemorage? were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Would the author/surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the products involved in the death cases? has an autopsy been performed for death cases? if so, can the results be shared? 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.Citation: surgery research and practice (2021); volume 2021, article id 6682935, 9 pages.Https://doi.Org/10.1155/2021/6682935 journal article.Note: events reported on mw# 2210968-2022-00050.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: preoperative predictors for 90-day mortality after pancreaticoduodenectomy in patients with adenocarcinoma of the ampulla of vater: a single-centre retrospective cohort study.The aim of this retrospective cohort study was to determine the preoperative factors related to 90-day severe morbidity and mortality after pancreaticoduodenectomy (pd).A total of 101 patients (47 male and 54 female; median age of 60 years; median bmi of 24.6 kg/m2) with a diagnosis of ampullary adenocarcinoma who underwent an open pancreaticoduodenectomy between january 2010 and december 2019.Two blake drains were placed around the pancreaticojejunostomy (pj) in all cases.Reported complications include postoperative mortality (n=11) due to clinically relevant postoperative pancreatic fistula type c in 5 patients and postpancreatectomy haemorrhage type c in 6 patients; clinically relevant postoperative pancreatic fistula (n=40); postpancreatectomy haemorrhage (n=28); overall morbidity (n=83%); severe morbidity/clavien-dindo =iiib (n=21).In conclusion, these findings suggest that baseline renal function measured by the egfr and liver function categorized with the albi grading are predictors of severe morbidity and mortality.Thus, they should be considered when selecting patients for pd or the use of neoadjuvant treatments.Further research is warranted.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent.Does the author/surgeon believe that ethicon product: blake drain involved caused and/or contributed to death (postoperative mortality)? the use of blake drains is part of our routine use during pancreaticoduodenectomy.We explained in detail our surgical technique.We have not analyzed the use of blake drains as a mortality factor in our cohort study.However, we do not believe this has been the reason for these events.Does the author/surgeon believe that ethicon: blake drain involved caused and/or contributed to non-death cases with post-op complications: postoperative pancreatic fistula, postpancreatectomy haemorrhage, overall morbidity, severe morbidity/clavien-dindo =iiib described in the article? please specify.We have not evaluated in our study the relation between blake drains and dismal outcomes.Does the author/surgeon believe there was any deficiency with the ethicon: blake drain, used for all cases in this study? we have not reported any deficiencies in your products as of yet to the best of my knowledge.Were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.We have not reported any deficiencies in your products as of yet to the best of my knowledge.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 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.-INDIA; 251, sector-6, imt; gurgaon 12205 0; IN 122050
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13157982
• MDR Text Key: 283232617
• Report Number: 2210968-2022-00051
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death