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 Failure to Anastomose (1028); Bacterial Infection (1735); Fistula (1862); Hemorrhage/Bleeding (1888)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products (blake drain and j-vac reservoir) involved caused and/or contributed to the post-, operative complications (fistula, hemorrhage, anastomotic leak, bacterial infection) described in the article? does the surgeon believe there was any deficiency with the ethicon products (blake drain and j-vac reservoir) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications (fistula, hemorrhage, anastomotic leak, bacterial infection).Were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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# 2210968-2021-00985 ,mw# 2210968-2021-00986.Citation: surgery today (2020) 50:248¿257 doi.Org/10.1007/s00595-019-01885-8.

Event Description

It was reported via a journal article that a drain was used.Title: early postoperative drainage fluid culture positivity from contaminated bile juice is predictive of pancreatic fistula after pancreaticoduodenectomy authors: tatsuo hata, masamichi mizuma, fuyuhiko motoi, kei nakagawa, kunihiro masuda1, masaharu ishida1, takanori morikawa, hiroki hayashi, takashi kamei, takeshi naitoh and michiaki unno citation: surgery today (2020) 50:248¿257 doi.Org/10.1007/s00595-019-01885-8.The aim of this retrospective study is to investigate the impact of early postoperative drainage fluid culture positivity on the development of clinically relevant postoperative pancreatic fistula (popf) after pancreaticoduodenectomy (pd).Between jan 2010 and dec 2018, 465 patients (n=295 male and n=170 female with a median age of 67 years (12¿87)) underwent pd for the following underlying diseases: pancreatic cancer (n=199), bile duct cancer (n=139), intraductal papillary mucinous neoplasm of the pancreas (ipmn) (n=60), neuroendocrine tumor (n=29), chronic pancreatitis (n=9), other pancreatic cystic neoplasms (n=8), duodenal cancer (n=11), and others unspecified (n=10).During the procedure, two drainage tubes of 6.3 mm blake drain and a j-vac suction reservoir (johnson and johnson) were placed cranial and posterior to the pancreaticojejunostomy (pj) and posterior to the hepaticojejunostomy (hj) sites, respectively.Grade b/c popf developed in (n=129) patients.Culture examination of the pj drainage fluid taken on postoperative day (pod) 1 was positive in (n=121) patients.Furthermore, of the 299 patients whose hj drainage fluid was cultured, (n=50) had positive culture results.The most identified microorganisms in the pj and hj drain fluids on pod 1 were enterococcus faecalis (50%), followed by enterobacter cloacae (15%), and enterococcus faecium (10%) and a small percentage (about 3%) of other bacterial species.Enterococcus and enterobacter were also found to be the predominant bacteria in the bile juice on pod 1.Other microorganisms include staphylococcus, streptococcus, klebsiella, baccilus, candida, citorobacter, aeromonas, sterotrophomonas, pseudomonas, serratia, corynebacterium, bacteroides, acinetobacter, chyseobacterium, and others.The study also noted that hj leakage was rare and that bacteria found in patients 2, 5, and 6 were from early leakage at the pj anastomotic site.Treatment with levofloxacin, carbapenem, and anti-mrsa drugs is recommended for contamination by enterococcus faecalis and/or enterobacter cloacae and an anti-mrsa drug is recommended for contamination by enterococcus faecium the study also shows that the drainage amylase level was significantly higher in patients with positive pj drainage culture results (median, 2411 iu/l) than in those with negative pj drainage culture results (median 694.5 iu/l).One patient suffered postoperative intraabdominal hemorrhage on the day of surgery.Pj drainage culture positivity on pod 1 in combination with an elevated drainage amylase level is an early predictor of grade b/c popf.Pj drainage culture positivity may be attributable to bile juice contamination caused by intraoperative spillage and early postoperative leakage from the pj anastomotic sites.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): DEGANIA SILICON LTD.-ISREAL; degania bet; emek hayarden 15130 ; IS 15130
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11268383
• MDR Text Key: 233307468
• Report Number: 2210968-2021-00985
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• 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