MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 19FR RND W/ 1/4IN TR; CATHETER, IRRIGATION

Model Number 2231

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

Patient Problem Unspecified Infection (1930)

Event Date 01/05/2022

Event Type  Injury  

Event Description

Title: the preventive effects of perioperative oral care on surgical site infections after pancreatic cancer surgery: a retrospective study.The aim of this study was to investigate the preventive effects of perioperative oral care on the incidence of surgical site infections after pancreatic cancer surgery.Between february 1, 2011, and december 31, 2018, 103 patients with pancreatic ductal adenocarcinoma who underwent pancreatic cancer surgery with curative intent were included in the study.75 patients received perioperative oral care by dentists and dental hygienists (oral care group), whereas 28 did not (control group).In the oral care group, there were 41 males and 34 females with a mean age of 70.4 +/-8.7 years and a mean bmi of 22.3+/-3.2 kg/m2.In the control group, there were 16 males and 12 females with a mean age of 64.6+/-10.0 years and a mean bmi of 23.0+/-3.3 kg/m2.Surgical procedures that were performed included pancreaticoduodenectomy, distal pancreatectomy, and standard lymphadenectomy.Before closing the surgical incision, the surgeon replaced their gloves, and the abdominal cavity was flushed with 10 l of saline solution.Abdominal drains (blake drains®,19 fr, ethicon) were placed around the pancreaticojejunostomy site or remnant pancreatic stump.Pancreatic juice was drained through an internal lost-stent or trans-jejunal external drainage tube.The abdominal fascia was closed with continuous double loop closure using monofilament absorbable sutures (pds ii, ethicon).The subcuticular layer was created using monofilament absorbable sutures (pds plus, ethicon) after irrigation of the subcutaneous tissue space with 1 l of saline.Finally, the skin was closed using a non-ethicon surgical tape.The reported complications included incisional surgical site infection (n=4) and organ/space surgical site infection (n=18).In conclusion, our results suggest that perioperative oral care may reduce the risk of developing surgical site infections after pancreatic cancer surgery.These findings need to be evaluated in future prospective studies.

Manufacturer Narrative

(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.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 any of the ethicon products involved caused and/or contributed to the surgical site infection described in the article? if so, was any medical or surgical intervention performed to treat the surgical site infections? does the surgeon believe there was any deficiency with any of the ethicon products 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.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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-05982 and 2210968-2022-05984.Citation: https://doi.Org/10.1007/s00520-021-06791-9.

Manufacturer Narrative

(b)(4).Date sent to the fda: 8/1/2022.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.The following information was requested but unavailable: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the surgical site infection described in the article? if so, was any medical or surgical intervention performed to treat the surgical site infections? does the surgeon believe there was any deficiency with any of the ethicon products 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.Patient demographics?.

• Brand Name: BLAKE SI DRAIN HBLS 19FR RND W/ 1/4IN TR
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA SILICON LTD.-ISREAL; kibbutz degania bet; emek hayarden; 15130 ; IS 15130
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15114056
• MDR Text Key: 296699788
• Report Number: 2210968-2022-05983
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003590
• UDI-Public: 10705031003590
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2231
• Device Catalogue Number: 2231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other