MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 4-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J304H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a picc line insertion on (b)(6) 2025 and suture was used.Post-op, on (b)(6) 2025, the patient noted purulent drainage at the insertion site.The patient was placed on antibiotics for port insertion site infection.The suture was trimmed previously.It was opined by the surgeon that there could have been delayed suture absorption.No further patient harm was reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H6 component code: g07002 device not returned.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: please see below.Will update the rest once confirmed by clinical user.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure over 18 years the diagnosis and indication for the picc line? cancer drug administration it was a port cath.On what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? was there slow absorption of the suture? yes please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Antibiotics for port insertion site infection.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.How much and what type of drainage is present in this wound? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no were any pre-op cleansing procedures changed recently? if yes, please describe.Other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? no harm reported surgeon¿s name? will product be returned? if so, please provide the return date and tracking information.No.
Additional Manufacturer Narrative
Product complaint#: (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.Additional information was requested, and the following was obtained: on what tissue was the suture used? they are used in fatty subcutaneous tissue and surface of the skin.What was the tissue condition (normal, thin, calcified, fragile, diseased)? most are normal, otherwise would not be chosen for port placement location.How was the suture placed (interrupted or continuous)? the 2.0 vicryl is subcutaneous and interrupted knots, usuallt 3-4, the 4.0 is used continuous.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? depends on the radiologist.How much and what type of drainage is present in this wound? purulent drainage noted to insertion site.Were any pre-op cleansing procedures changed recently? if yes, please describe.No, we use chlorhexadine, unless the patient is allergic, then we use betadine.It must be dry prior to drape application.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the port insertion/sutures could have contributed or led to this port site infection and the patient was placed on antibiotics for same.
Additional Manufacturer Narrative
Product complaint # (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.Additional information: d4 expiration date, d4 udi number, h4, h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: VCL CT BRD VIO 27IN 4-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22090923
• Report Number: 2210968-2025-05902
• Device Sequence Number: 8022585
• Product Code: GAM
• UDI-Device Identifier: 10705031038615
• UDI-Public: (01)10705031038615(17)290331(10)100G2P
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: J304H
• Device Lot Number: 100G2P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 07/28/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/18/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown