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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Fistula (1862); Blood Loss (2597); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 2/22/2018.(b)(4).Citation: br j surg.Jan 2014; 101(2):100-8.Doi: 10.1002/bjs.9362.

Event Description

Literature article: diagnostic value of abdominal drainage in individual risk assessment of pancreatic fistula following pancreaticoduodenectomy.Pancreaticoduodenectomy (pd) remains the mainstay of potentially curative treatment of malignant diseases confined to the pancreatic head, distal bile duct, and periampullary region of the duodenum.Post-operative pancreatic fistula (popf) is the main cause of the considerable post-operative morbidity and may lead to a complex post-operative course, high frequency of re-operations, and increased mortality.The aim of the study was to assess the predictive value of drain pancreatic amylase (dpa), plasma pancreatic amylase (ppa), and serum crp for popf and to assess the value of prophylactic abdominal drainage in predicting pancreatic fistula formation following pd.Several predictive markers for pancreatic fistula following pd were evaluated systematically.Validated popf risk factors were taken into account and the systemic inflammatory response and the dynamics of pancreatic amylase levels in drains and the systemic circulation during the early postoperative course were investigated.The study consist of 315 patients, majority had resection of a pancreatic ductal adenocarcinoma and few patients with chronic pancreatitis underwent surgery owing to suspicion of malignancy.A standard kausch¿whipple pancreaticoduodenectomy with lymphadenectomy excluding station 9 and 14d was carried out in all patients.The procedure was completed by a standard end-to-side hepaticojejunostomy, a stapled side-to-side gastrojejunostomy, and a stapled side-to-side enteroenterostomy.At the end of the procedure, 2 silicone 4-channel blake drains were inserted.The left drain was placed close to the pancreaticojejunostomy, and the right drain mainly to drain the area around the hepaticojejunostomy.Both drains were fixed with skin sutures and connected to a 1000-ml bag to remove fluid by gravity.Complications included popf (grade b/c) in 48 patients.Popf grade c was treated conservatively in 7 patients and required completion pancreatectomy in 16 patients.Other complications included delayed gastric emptying in 43 patients, abscess in 20 patients, wound complications in 13 patients, gastrointestinal bleeding in 11 patients, abdominal bleeding in 10 patients, bile leakage in 8 patients, and gastric leakage in 1 patient.It was concluded that postoperative percutaneous drainage allowed safe management of significant abdominal collections and that the routine use of prophylactic abdominal drains was no longer considered mandatory.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/14/2020.

• 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 0151
• MDR Report Key: 7288811
• MDR Text Key: 100693305
• Report Number: 2210968-2018-70986
• Device Sequence Number: 1
• Product Code: GBX
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• 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: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention