MAUDE Adverse Event Report: ETHICON INC. CATGUT PLAIN 3-0 70CM (1)SH-1; SUTURE, ABSORBABLE, NATURAL

Catalog Number G318T

Device Problem Material Separation (1562)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and suture was used.During the procedure, the needle completely detached from the thread during suture.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 3/19/2024.H6 component code: g07002 - device not returned.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.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: (b)(4): during suture of the left tonsil store, two needles were released entirely from the threads inside the mucosa and muscle plane.(b)(4): the same happened in 3 moments with a colleague during suture.Please provide an answer for each case: was there any adverse consequence associated with the patient? could you please advise if the 3 moments (pull off suture needle) happen during the same surgery? please provide the lot number: device return status.Please document the shipment tracking number: please provide the source or name of person providing answers to follow-up questions: 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.Related reports: 2210968-2024-03187 and 2210968-2024-03188.

• Brand Name: CATGUT PLAIN 3-0 70CM (1)SH-1
• 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: 18934529
• MDR Text Key: 338036414
• Report Number: 2210968-2024-03189
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G318T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1