MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 5-0 S/A P-2 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP503G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date; and a suture was used.During the procedure, the needle separated from the suture when the nurse pulled the suture.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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 review of the batch manufacturing records was conducted, and no related non-conformances were identified.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.Did the needle detach during use on the patient or before use on the patient? attempts are being 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.H6 component code: g07002 device not returned.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d 9.Device available for evaluation?, h 3.Device evaluated by manufacturer?, h 6.Component code, h 6.Type of investigation, h 6.Type of investigation, h 6.Investigation conclusions.Additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer? investigation summary: the product was returned to ethicon for evaluation.Thee returned product revealed that it was received two open samples that pertain to product code vcp503.During the analysis of the sample, it was found that the sample was used.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement.Based on the information currently available, a short insertion issue was identified as pull out during the investigation of the sample received.Device history review: a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances 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.

• Brand Name: VCL+ UD 18IN 5-0 S/A P-2 PRM
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18934733
• Report Number: 2210968-2024-03196
• Device Sequence Number: 7027428
• Product Code: GAM
• UDI-Device Identifier: 10705031053908
• UDI-Public: 10705031053908
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: VCP503G
• Device Lot Number: TDMHSK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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