MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 36IN 0 S/A CT-1; SUTURE, ABSORBABLE, NATURAL

Model Number	924H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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.(b)(4).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.What instruments were used to grasp the needle? where was the needle grasped during use? was the needle piece retrieved during the same procedure? 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 the post-operative care changed due to this event? please specify.Patients current status?.
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2022 and suture was used.The needle broke off and fell into the patient.After a one hour delay and an x-ray it was located and retrieved from the uterus.The case was completed with no patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: what instruments were used to grasp the needle? needle driver and russian forceps where was the needle grasped during use? at the midpoint.Was the needle piece retrieved during the same procedure? yes, after approx.1 hour.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? yes, the patient experienced an intrapartum hemorrhage.Was the patient's treatment altered in anyway due to the prolonged surgery time? if yes, please explain.Yes, patient needed several uterotonic medications.Was the postoperative care changed due to this event? please specify.Yes, patient required a massive transfusion protocol immediately postop.Patient¿s current status? excellent.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 followup report will be filed as appropriate.Corrected information: b 1.Is adverse event, b 2.Is required intervention.

• Brand Name: GUT CHR UD 36IN 0 S/A CT-1
• Common Device Name: 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: 15714194
• Report Number: 2210968-2022-09034
• Device Sequence Number: 6600943
• Product Code: GAL
• UDI-Device Identifier: 10705031022768
• UDI-Public: 10705031022768
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 924H
• Device Catalogue Number: 924H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown