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

Catalog Number 844T

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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.Additional information was requested, and the following was obtained via: it was mentioned that "in conjunction with the case of counterfeit nylon".Has this event been previously reported to ethicon? if so, provide the respective reference number(s).Yes it was , case number # (b)(4).Please provide the lot number.We do not have this information were there any patient consequences? no, thankfully the sutures were not taken to the or.Are there any photos available for visual analyisis? no, sutures were destroyed by the institution.What is the event date? tuesday 26th it was reported to the distributor, they haven¿t had the formal training of the complaints process at that time.This has been corrected.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) manuel torellas ¿ brand manager of ethicon for our distributors crumar.Events reported via: 2210968-2023-07937, 2210968-2023-07938, 2210968-2023-07936.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Before use on the patient, the following was reported: in conjunction with the case of counterfeit nylon i would also like to report a case of manipulation of the quality of the suture where a customer from our west zone, specifically in the city of *(removed) acquired 4 sachets of catgut simple 0 844t and they tell me that in the expiration part of the envelope has a sticker that alters the original impression.Knowing that the suture was altered unfortunately they destroyed the envelopes and are refused to give me information of the supplier who gave them the suture claiming that it is internal information, who did it in good faith, acknowledged the error and proceeded to make the refund of the money.Unfortunately it is all the information i have so far, but i considered it appropriate to name it to monitor and prevent new cases.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: CATGUT PLAIN 0 70CM (1)CT-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: 17957306
• MDR Text Key: 325942737
• Report Number: 2210968-2023-07935
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: VE
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 844T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2023
• 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