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

Model Number	VCP260H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (b)(4) device not returned.This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts have been made to retrieve the device.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: what was the initial procedure? hysterectomy and cystoscopy what was the lot number? the packaging was thrown away, not knowing it would be need.What was used to complete the procedure? another suture needle did the patient suffer from any consequence due to the issue (breakage needle)? no consequences other than another procedure to find the retained foreign body.Did any piece of breakage needle fell into the patient's body? if yes did the surgeon recover the broken pieces? yes the broken section of needle was found.Trade name: (b)(4).Active ingredient(s): triclosan.Dosage form: suture/solid/parenteral.Strength: 275 g/m.
Event or Problem Description
It was reported that a patient underwent a hysterectomy and cystoscopy procedure on (b)(6) 2021 and suture was used.During the procedure, the needle broke.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ UD 27IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12058372
• Report Number: 2210968-2021-05794
• Device Sequence Number: 4615399
• Product Code: GAM
• UDI-Device Identifier: 10705031051805
• UDI-Public: 10705031051805
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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 Model Number: VCP260H
• Device Catalogue Number: VCP260H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 84