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

Model Number	VCP959H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/1/2023.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, 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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, the following was obtained: when was the suture broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify during removal from package please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu) (b)(6).H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned product determined that it was received, one winding former with a suture piece that pertains to the product code vcp959h.During visual inspection of the returned sample, it was noted that the suture piece was partially dispensed.The suture was dispensed, and the strand has begun with a degradation process caused by exposure to the environment.In addition, the foil was not returned for evaluation.The product code vcp959h contains an absorbable suture.As the sample was received open, the time of exposure to the environment could not be determined and the functional test cannot be performed.The manufacturing records could not be reviewed as the batch number is unknown.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Trade name - irgacare; active ingredient(s)- triclosan; dosage form - suture/solid/parenteral; strength -= 275 g /m; related reports: 2210968-2023-04018.
Event or Problem Description
It was reported from the analysis of the returned product that suture degradation was observed, the strand has begun with a degradation process caused by exposure to the environment.It was reported during an unknown procedure on an unknown date a suture was used.During removal from package, the suture broke.No patient harm was reported.Additional information was requested.

• Brand Name: VCL+ UD 36IN 1 S/A CT
• 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: 17043456
• Report Number: 2210968-2023-04017
• Device Sequence Number: 15638258
• Product Code: GAM
• UDI-Device Identifier: 10705031056237
• UDI-Public: 10705031056237
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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: VCP959H
• Device Catalogue Number: VCP959H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/01/2023
• 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