MAUDE Adverse Event Report: ETHICON, LLC MONOCRYL; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y398H
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had a cesarean delivery (c-section).After closure, it was noted that the tip of a suture needle had broken off.It was too small of a piece to use x-ray or find it on wound exam.The nurse estimates that the size of the broken tip was at less than 2 mm.The needle was not kept, but we have the package.

• Brand Name: MONOCRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON, LLC; 475 c street; los frailes industrial park, suite 401; guaynabo PR 00969
• MDR Report Key: 10939922
• Report Number: 10939922
• Device Sequence Number: 4329824
• Product Code: GAN
• UDI-Device Identifier: 10705031059092
• UDI-Public: (01)10705031059092
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/01/2020
• Report Date (Section F): 12/01/2020

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
• Operator of Device: Health Professional
• Device Model Number: Y398H
• Device Catalogue Number: Y398H
• Device Lot Number: PJZ880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 78
• Date Report Sent to FDA: 12/01/2020