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

Catalog Number	VCP496H
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B)(4).H6.Component code: g07002 - device not returned.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: -was surgery delayed due to the reported event? -- no, -was procedure successfully completed? -- yes, -status/ outcome / consequences -- no, the following information was requested, but unavailable: -were fragments generated? -- unknown, -if yes, were they removed easily without additional intervention? -- unknown, -patient was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: -- unknown, - is the patient part of a clinical study -- unknown, 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.* are there photos available for visual analysis? a manufacturing record evaluation was performed for the finished device and no non-conformances / manufacturing irregularities related to the malfunction were identified.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.There was a black dot on the suture while the nurse just opened the package.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device evaluation pending.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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information: h6, d9.Corrected data: b5 event year added.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2025 and suture was used.There was a black dot on the suture while the nurse just opened the package.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (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.Additional information: h6, d9, h3 h3 investigation summary: the product was returned to ethicon for evaluation.One open sample was received for analysis.Product code vcp496h.Upon initial inspection of the returned sample, it was observed that an extra needle suture associated with the same product code was found within the labeled winding former.This resulted in an incorrect count of components in the package, which deviates from the requirements for product y426h, which specifies a single-armed strand per package.Furthermore, one section of the suture was noted to be dirty or to have a black stain that does not appear to be related to the production process.The sample shipped for further analysis for structural analysis - fourier transform infrared spectroscopy (ft-ir).Based on the information currently available, the wrong number of components and foreign matter were identified during the investigation of the sample received.This product issue will be addressed through the quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21878388
• Report Number: 2210968-2025-04320
• Device Sequence Number: 18302980
• Product Code: GAM
• UDI-Device Identifier: 10705031053786
• UDI-Public: (01)10705031053786(17)281130(10)TP2AAB
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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: VCP496H
• Device Lot Number: TP2AAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 05/23/2025; 06/23/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/20/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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