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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pleural Effusion (2010); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Citation: world j surg (2015) 39:727¿731; doi 10.1007/s00268-014-2860-0.

Event Description

Title: method of bilateral pleural drainage by single blake drain after esophagectomy author(s): yukiko niwa, masahiko koike, hisaharu oya, naoki iwata, daisuke kobayashi, mitsuro kanda, chie tanaka, suguru yamada, tsutomu fujii, goro nakayama, hiroyuki sugimoto, shuji nomoto, michitaka fujiwara, yasuhiro kodera.This retrospective study aimed to evaluate the performance of bilateral pleural drainage by a single 15-f blake drain (bdsd) by comparing its fluid drainage and incidence of left pleural effusion and left atelectasis to those of a conventional drain.Between apr2012 and jun2014, 104 patients with thoracic esophageal carcinoma underwent right transthoracic subtotal esophagectomy.Methods of drain placement were reviewed in two groups: bdsd group (n=54; n=48 male, n=6 female; mean age sd 66±8 years) and conventional drain (cd) group (n=50; n=42 male, n=8 female; mean age sd 66±8 years).In cd group, a 19-f blake drain was inserted into thoracic cavity thorough the fifth intercostal muscle and tip was placed in the right dorsal apical area, while a 15-f blake drain was inserted from the left thoracic cavity to right thoracic cavity in bdsd group.Following drainage placement, there were reported cases of left pleural effusion (n=40 cd group; n=5 bdsd group) and left lower lobe atelectasis (n=33 cd group; n=3 bdsd group).Four patients from cd group who developed left pleural effusion necessitates thoracentesis.Additionally, one patient from bdsd group had left chest pain that was thought to be due to the contact between the drain tip and diaphragm.The study demonstrated that the 15-f blake drain was able to evacuate bilateral pleural effusion more effectively and incidence of left pleural effusion and left atelectasis were lower.

Manufacturer Narrative

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

• 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: 7306634
• MDR Text Key: 101282022
• Report Number: 2210968-2018-71127
• 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: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• 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