MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 0 S/A CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP267H
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
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.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.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.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.Was there any adverse consequence associated with the patient? - please provide the lot number: - device return status: photo analysis: this is an analysis of two photos submitted to ethicon for review.During the visual analysis the following was observed: the photos show that an aluminum package was observed, product code: vcp267h, the package has marks, the image is not clear to determine the failure mode of the damaged packages.Based on the photo review, the event describe is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 275 g/m.Events reported via: 2210968-2022-06831, 2210968-2022-06833, 2210968-2022-06834 and 2210968-2022-06835.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2022 and suture was used.Before use on the patient, it was reported by an employee per the account: "the or at ld has been noticing small holes in the suture packaging after they open them.The individual sutures come in ¿foil¿ packs and if the packs get a bend or crease in them, there is a chance it may create a whole.Ethicon does package some of their suture like prolene in a clear plastic peel packs that hold up better." it is unknown if the devices are available for return.Adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ UD 27IN 0 S/A CP-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15272458
• Report Number: 2210968-2022-06832
• Device Sequence Number: 5880289
• Product Code: GAM
• UDI-Device Identifier: 10705031051874
• UDI-Public: 10705031051874
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2022

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 Model Number: VCP267H
• Device Catalogue Number: VCP267H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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