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

Catalog Number	VCP214H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 2/18/2026.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Additional information was requested, the following was obtained: in how many procedures did each reported incident occur? -how many pull-offs were there? how many broken needles were reported? in how many procedures did the needle break? in the procedures where the needle broke.Were x-rays taken to locate the needle piece(s)? what measures were implemented to retrieve the broken piece? was there any additional tissue damage resulting from the search for the needle piece? does a fragment of the needle remain in the patient¿s tissue? if so, is there any plan in place to remove the needle piece in the future? if so, could you please provide the scheduled date for the removal? in which tissue structure was the broken needle located? what is the surgeon¿s opinion of the potential consequences for the patient? could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided.Please provide the source or name of person providing answers to follow-up questions: -there were a total of 6 procedures that the reported incident occurred.There were 5 pull-offs the needle broke off of the suture string on 5 patients in procedures where the needle broke off.Xrays had to be taken on 1 patient to locate the needle in the patients body measures implemented were that the np had to come retrieve the foreign body from the patient's body in the catheter tunnel site.There was no additional tissue damage the needle did not remain in the patients body.I cannot ship the item in question.They were opened and used on patients.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported while suturing catheters in place and/or suturing port incisions on patients in radiology, the needle has broken off from the suture.One of the needles broke off underneath the patient's skin but given it was open incision, it was able to be removed immediately.It breaks off right where the needle and suture come together.This has happened with 5 different patients and with different staff suturing.Another incident was when the suture frayed and did not come apart but this also happened at the same spot on the product.There are no injuries or adverse event reported.Additional information was requested.

• Brand Name: VCL+ UD 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.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24376446
• Report Number: 2210968-2026-01701
• Device Sequence Number: 5583420
• Product Code: GAM
• UDI-Device Identifier: 10705031076839
• UDI-Public: 10705031076839
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCP214H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown