MAUDE Adverse Event Report: ETHICON INC. CATGUT PLAIN 2-0 70CM (1)BB; SUTURE, ABSORBABLE, NATURAL

Catalog Number A2414T

Device Problems Break (1069); Defective Component (2292)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.During suturing, the thread unraveled and tangled several times and finally broke several times.This thread has been dry, despite the liquid that comes in the package.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint #: (b)(4).Device not returned.Attempts have been 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.Additional information was requested, and the following was obtained: have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).The hospital never reported the previous cases.In fact, they said that the doctor only reported it to them now, because he noticed that the suture still has the same problem.Therefore, we do not know how many times there were previously device return status: there is no sample to be analyzed.Doctors discarded it.The following information was requested, but unavailable: did the event occur during one or multiple patient procedures? what is the total number of procedures? the single complaint was reported with multiple events.There are no additional details regarding the additional events.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.Did the suture package contained the expected tubing fluid? was the suture package dry? what tissue was being approximated/ sutured? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw #: 2210968-2022-05452.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, 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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 8/8/2022.Component code: g07002 no device returned.Additional information was received: as i pointed out in the attachment on the day (fri 17/06/2022 11:21), the hospital never reported the previous cases.In fact, they said that the doctor only reported it to them now/at the same time that we also received the complaint ¿ this is because he realized that the thread still has the same problem.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.

• Brand Name: CATGUT PLAIN 2-0 70CM (1)BB
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente; dutra, km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15009604
• MDR Text Key: 304213262
• Report Number: 2210968-2022-05453
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: A2414T
• Device Lot Number: AP2093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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
• Patient Sex: Male