MAUDE Adverse Event Report: ETHICON INC. J-VAC RESERVOIR UNKNOWN PRODUCT; CATHETER AND TIP SUCTION

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

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested however not received.To date product not received.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 (n=5) surgical site infection caused by staphylococcus epidermidis (n=10) surgical site infection caused by mrsa) 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 (n=5) surgical site infection caused by staphylococcus epidermidis (n=10) surgical site infection caused by mrsa.).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# 2210968-2021-01036.Citation: european journal of orthopaedic surgery & traumatology (2018) 28:1053¿1057 doi.Org/10.1007/s00590-018-2163-5.

Event Description

It was reported via journal article that a reservoir was used.Title: prediction of surgical site infection in spine surgery from tests of nasal mrsa colonization and drain tip culture authors: kazuyoshi kobayashi, kei ando, kenyu ito, mikito tsushima, masayoshi morozumi, satoshi tanaka, masaaki machino, kyotaro ota, naoki ishiguro, and shiro imagama citation: european journal of orthopaedic surgery & traumatology (2018) 28:1053¿1057 doi.Org/10.1007/s00590-018-2163-5 the aim of this prospective study is to examine relationships among surgical site infection (ssi) after spinal surgery, nasal methicillin-resistant staphylococcus aureus (mrsa) colonization, and wound drain culture results.Between jan 2012 to dec 2013, 132 patients (n=66 female and n=66 male with mean age of 45±24 years and mean bmi of 24.2±7.1 kg/m2) underwent spinal surgery for the following diagnoses adult deformity, pediatric deformity, degenerative disease, ossification of the posterior longitudinal ligament/ossification of the yellow ligament (opll/oyl), tumor and others.A closed suction drainage system was applied in all operations.A 10-fr drain j-vac (ethicon) tube was placed subfascially and brought out through a separate skin incision.The drain was removed under sterile conditions when drainage was < 100 ml in the previous 24 h or the drain had become serous and not bloody.After removal, 3 cm of the inner part of the tube was cut off and put into a sterile transport tube, and drain tips were inoculated in 0.3% sodium thiogluconate.Postoperative complication included surgical site infection caused by staphylococcus epidermidis (n=5) and surgical site infection caused by mrsa (n=10).Mrsa carriers were not necessarily associated with mrsa infection, but were related to a positive drain tip culture and ssi, which might be due to endogenous skin bacteria.Therefore, possible ssi should be considered in patients with nasal mrsa colonization or bacteria detected in a drain tip culture.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 4/12/2021.Corrected information: b1, b2, h1, h6- additional information was received that there are no issues with this device in the patient event.Therefore, this medwatch report will be voided.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: J-VAC RESERVOIR UNKNOWN PRODUCT
• Type of Device: CATHETER AND TIP SUCTION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11273919
• MDR Text Key: 233738944
• Report Number: 2210968-2021-01035
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• PMA/PMN Number: CL II EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention