MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP496H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
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.Additional information was requested and the following was obtained: did the needle break or did the needle separated from the suture during the procedure? yes.Were x-rays performed to localize the needle? yes.Was the needle removed from the patient? yes.Any other patient consequences? if yes, what medical/surgical intervention was provided.No.If needle piece is still retained please provide size and location.N/a.Are there plans to remove the retained needle piece? all retained needle was be removed.Procedure name and date? caesarean section.Event date? (b)(6) 2022.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).A manufacturing record evaluation was performed for the finished device rh2abd/vcp496h32 and no non conformances/ manufacturing irregularities related to the malfunction were identified.Trade name - irgacare®.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 caesarean section on (b)(6) 2022 and suture was used.The patient was diagnosed with covid-19 so the healthcare professionals wore the ppe to perform the procedure.When hcp performed wound closure, needle breakage occurred and fall was noted.The surgeon opined that under tight timeframes, wearing ppe may have caused deviation on the forces/point acting on a needle during operation.Considered that tight timeframes and special covid-19 case, hcps decided to stitch up a wound first, and then perform x-rays to localize the needle, and remove all retained needle piece from the patient.The surgery was successfully completed with no impact on effectiveness of surgery.Patient is fine.No negative outcome was found.Additional information was requested.

• Brand Name: VCL+ UD 18IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14887354
• Report Number: 2210968-2022-05066
• Device Sequence Number: 15029399
• Product Code: GAM
• UDI-Device Identifier: 10705031053786
• UDI-Public: 10705031053786
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

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 Expiration Date: 06/30/2026
• Device Model Number: VCP496H
• Device Catalogue Number: VCP496H
• Device Lot Number: RH2ABD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: Female