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 02/20/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested however 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 (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 (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# 2210968-2021-01040, mw# 2210968-2021-01042.Citation: bull tokyo dent coll (2020) 61(1): 1-7 doi:10.2209/ tdcpublication.2018-0069.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via journal article that a reservoir was used.Title: investigation of surgical site infections and bacteria detected following neck dissection in patients with oral cancer.Authors: masashi iwamoto, takamichi morikawa, masato narita, takahiko shibahara, and akira katakura.Citation: bull tokyo dent coll (2020) 61(1): 1-7.Doi:10.2209/ tdcpublication.2018-0069.The aim of this study was to investigate neck infections after neck dissection in oral cancer patients with the aims of elucidating the development of surgical site infections (ssis) and their relationship with the results of bacterial culture.Between jan 2012 and dec 2016, a total of 86 study participants (n=54 male and n=32 female with mean age of 60.1 years (range 22-87)) with oral squamous cell carcinoma were enrolled from among oral cancer patients who underwent neck dissection (including those in whom neck dissection only was performed for late cervical lymph node metastasis).During the procedure, the placement of 2 or 3, 15 fr, portable low-pressure continuous suction systems j-vac (ethicon) approximately 10¿15 cm into the cervical wound was performed; and fixed sutures in the skin.An ssi was developed in (n=28) of the total of 86 patients, including in 23 of 50 patients in whom the single surgical field extended to the oral cavity and neck when the primary tumor and tissue to be dissected were resected en bloc; and in 5 of 36 patients in whom resection was performed separately for the primary tumor and tissue to be dissected or neck dissection only was carried out for late lymph node metastasis.Of the 28 ssis, ssi was seen in 10 patients with mandibular gingival cancer and 13 with cancer of the tongue and floor of the mouth.Among the total of 86 patients enrolled, bacterial species detected in ssi patients only comprised of peptostreptococcus spp., obligate anaerobic grampositive, non-spore-forming rods, prevotella/porphyromonas spp., and obligate anaerobic gram-negative rods.In patients with an ssi, prevotella/porphyromonas spp.Were observed where the primary site of the tumor was the mandibular gingiva.Use of a drain catheter means there will be communication between the interior and exterior of a wound, which may provide a pathway for spread of infection.The authors believe that the longer the drain is left in place, the higher the risk of infection.In the present study, the results showed that infections tended to occur when the drains were in place for longer.However, the risk of an ssi is also higher in cases where there is a large amount of drainage at the time the drain is removed, and so the timing of drain removal needs to be determined by taking into account the status of both.When the amount of drainage is large, necessitating the drain has to remain in place for a protracted period of time, the administration of antibiotics needs to be prolonged, taking into consideration neck compression and the emergence of drug-resistant bacterial strains.Perioperative oral management is performed in all patients to prevent infection.It includes preoperative oral care performed by an oral hygienist; 2 g/day of cefazolin sodium (cez) administered intraoperatively and postoperatively for 3 days.A survey of ssis following neck dissection was conducted.The results suggest that selection of antibiotics appropriate to each patient and perioperative oral care are important in preventing ssis.

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: 11274181
• MDR Text Key: 231244702
• Report Number: 2210968-2021-01042
• 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