MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 3-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP219H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Trade name: irgacare®.Active ingredient(s): triclosan.Dosage form: suture/solid/parenteral.Strength: 275g/m.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: what was done to retrieve the broken piece? for example, another incision, second surgery? the broken needle was found and removed in the same surgery.How was the "puncture injury" treated? (re-operation; extended surgery; prescription steroids; antibiotics prescribed; other medication prescribed)? if so, please clarify.Contacted with the sales rep today via phone and the information requested is unknown.What is the most current patient health status and condition? contacted with the sales rep today via phone and the information requested is unknown.Did the patient need any different type of post op care due to the "puncture injury"? contacted with the sales rep today via phone and the information requested is unknown.Was the puncture injury to the patient? please describe.Was the puncture injury to the nurse midwife? please describe.The puncture injury to the patient, other information is unknown.
Event or Problem Description
It was reported that a patient underwent a vaginal delivery on (b)(6) 2023 and suture was used to suture the lateral episiotomy portion of the patient.During the procedure, after the midwife has sewed more than ten stitches, the midwife needed to hide the suture into the vagina and passed it through the vaginal opening.At this point, it was found that the needle was broken in the vaginal tissue.The midwife carefully searched for a broken needle in the vaginal tissue and took it out.When taking it out, it caused puncture injury to the patient.The original suture was taken out together, and upon examination, the tail of the needle was broken.The rear midwife used another suture that was previously punctured to knot and complete the suture.Due to the timely detection, the broken needle did not remain in the tissue.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/8/2023.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following additional information was received: the layer sewing with the reported device was perineal skin and perineum, and the sewing method was continuous suturing.

• Brand Name: VCL+ UD 27IN 3-0 S/A SH-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16644029
• Report Number: 2210968-2023-02214
• Device Sequence Number: 6157607
• Product Code: GAM
• UDI-Device Identifier: 10705031051720
• UDI-Public: 10705031051720
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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: VCP219H
• Device Catalogue Number: VCP219H
• Device Lot Number: SBMLEP
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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 Age: 29 YR
• Patient Sex: Female