MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 0 S/A CTB CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number D10083

Device Problems Material Separation (1562); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.H3 analysis summary: according to the information received, it was reported by a sales rep that, the number of needles in the package was incorrect.The product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned sample determined that it was received eight detached needles and one suture in the winding former that pertained to the product code d10083.This product code is a control release and requires eight strands per packet.Overall review of the returned sample shows that all needles were used.In further investigation, short insertion was observed in the strand.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.Additionally, the winding former was examined to confirm if fewer needles were placed in the tray and marks were noted in all slots from the winding former.Therefore, the reported event could not be confirmed.Based on the information currently available, the short insertion issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.The winding former was examined in order to confirm if the needle-suture combination was placed in tray and not marks were noted.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.The following information was received: abnormal number of needle-sutures in this complaint means that the number of needle-sutures in one package was insufficient.Original description : the number of needles in the package was incorrect.Correct description : the number of needles in the package was less than the correct quantity.Also, the suture was not attached to the needle.Lot number : tcmere - please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).=>ryohei mori.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date, and suture was used.Before use on the patient, it was reported that the number of needles in the package was less than the correct quantity.Visual inspection was conducted on the returned device.The returned sample determined that it was received eight detached needles and one suture in the winding former that pertained to the product code d10083.This product code is a control release and requires eight strands per packet.There were no adverse consequences to the patient.No further information was provided.

• Brand Name: VCL+ VIO 8X18IN 0 S/A CTB CR
• Type of Device: 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: 18968947
• MDR Text Key: 339143153
• Report Number: 2210968-2024-03065
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031203181
• UDI-Public: 10705031203181
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K132580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D10083
• Device Lot Number: TCMERE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1