MAUDE Adverse Event Report: Ethicon Inc. Coated VICRYL; Suture, Absorbable, Synthetic

Catalog Number	VCPB840D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used.During surgery, the needles were detached too easily.Three packages from the same lot were opened, but they all had the same defect, so the remaining three unopened packages from the same lot were also retrieved.It was a control release needle.Another product was used to complete the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: - did the reported issue contribute to any patient adverse consequences? no.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.- when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.B03 h3 investigation summary: the product was returned to eth for evaluation.Visual inspection confirmed receipt of three (3) unopened representative samples for analysis.Product code vcpb840d is a control-release product configuration containing eight (8) single-armed suture strands per packet.Upon initial inspection of the returned samples, no external damages were observed on the packets.The packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand; no anomalies were observed during evaluation.A functional test was performed using instron equipment, and the pull force results met with the requirements.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.B01 h3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one winding former with three detached needles and five needle suture combinations outside the foil packet was received for analysis.Product code vcpb840d is a control-release product configuration containing eight (8) single-armed suture strands per packet.Upon visual inspection of three detached needles, the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined with magnification, and no suture remnant was noted.The sutures were not returned for evaluation.In addition, five needle-suture combinations were visually inspected, the swage and attachment area were noted to be as expected in all needles.Besides that, no anomalies or issues related to pull-off were observed during the evaluation.Functional testing could not be performed due to the suture is absorbable and its duration of environmental exposure was unknown.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Per the condition of the returned sample, no conclusion could be reached as to what caused the reported complaint.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Device history review: a manufacturing record evaluation was performed for the finished device 10c6xd / vcpb840d batch number, and no non-conformances were identified.Expiration date: oct/31/2030 date of mfg.: nov/13/2025 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.

• Brand Name: Coated VICRYL
• Common Device Name: Suture, Absorbable, Synthetic
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): Ethicon Inc.-Juarez; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50870664
• Report Number: 2210968-2026-09526
• Device Sequence Number: 9314155
• Product Code: GAM
• UDI-Device Identifier: 10705031056626
• UDI-Public: (01)10705031056626(17)301031(10)10C6XD
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K181652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: VCPB840D
• Device Lot Number: 10C6XD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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