MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 54IN 0 NON NDL; SUTURE, ABSORBABLE, NATURAL

Catalog Number L104G

Device Problems Break (1069); Packaging Problem (3007)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date in 2023 and suture was used.They have a defective suture, the reels were cracked and the thread kept breaking apart.There were no adverse consequences reported.Additional information has been requested.

Manufacturer Narrative

(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.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.It was reported that the "reels were cracked and the thread kept breaking apart" please confirm the number of reels that were cracked during this procedure.Please confirm the number of sutures that broke during this procedure.When did the suture break (in the package, during removal from the package, during handling before use on patient or during use on the patient)? please specify.Can you identify the lot number of the product that was used? 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.Related events captured via: 2210968-2023-10044.

• Brand Name: GUT PL UD 54IN 0 NON NDL
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• 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: 18375011
• MDR Text Key: 331374738
• Report Number: 2210968-2023-10045
• Device Sequence Number: 1
• Product Code: GAL
• UDI-Device Identifier: 10705031044845
• UDI-Public: 10705031044845
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L104G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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