MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 1 S/A CTXB; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPB977H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (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.Investigation summary: returned for evaluation.Visual inspection and functional testing were conducted on the returned device.One opened box with twenty-seven packets of product code vcpb977h was returned to ethicon for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packets.As per sampling plan visual inspection were performed to thirteen samples, the packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.Functional test was performed, and the pull force result were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch it should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained: when was the needles were popping off very easily from the suture (in the package, during removal from package, during handling or during use on the patient)? please specify.It occurred when the surgeon was suturing inside the patient during closure of the wound.How many products needles were popping off very easily from the suture? n/k (not known).They said a few as they don¿t report if only one, exact quantity unknown.Did the event occur during one or multiple patient procedures? n/k (not known).What is the total number of procedures? n/k (not known).Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Not that we are aware of from our territory.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 unknown procedure on (b)(6) 2022 and suture was used.During the procedure, needles were popping off very easily from the suture when suturing inside the patient during closure of the wound.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL+ UD 36IN 1 S/A CTXB
• 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; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14609229
• Report Number: 2210968-2022-04343
• Device Sequence Number: 4638056
• Product Code: GAM
• UDI-Device Identifier: 10705031056770
• UDI-Public: 10705031056770
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• 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): 06/06/2022

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: 07/31/2026
• Device Model Number: VCPB977H
• Device Catalogue Number: VCPB977H
• Device Lot Number: RJMBCL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/06/2022
• Date Device Manufactured: 08/03/2021
• 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: Unknown