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

Catalog Number 813T

Device Problems Break (1069); Material Separation (1562); Defective Component (2292)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.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.Could you please provide the event date? how many devices presented a difference in the thickness of the sutures during this single procedure? how many devices presented suture breakage during this single procedure? how many devices presented needle and thread detachment during this single procedure? how many minutes was the procedure delayed? were there any unexpected outcomes or complications as a result of the prolonged surgery time? was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain was there any adverse consequence associated with the patient as a result of the bleeding? were there any patient consequences?.

Event Description

It was reported that a patient underwent a c-section in (b)(6) 2021 and suture was used.The surgeon stated that there was a difference in the thickness of the sutures and the suture broke and the needle thread detached.The procedure was completed successfully.The device was already discarded because they were contaminated.The failure of the suture caused a delay in the care of a patient with bleeding.There were no adverse patient consequences.Additional information was requested.

Manufacturer Narrative

Date sent to fda: 7/23/2021.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 CHROMIC 1 70CM (1)CT-1
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11866534
• MDR Text Key: 268355904
• Report Number: 2210968-2021-04869
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

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: 813T
• Device Lot Number: AN7127
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1