MAUDE Adverse Event Report: ETHICON, INC. 3-0 VICRYL PLUS RB-1 SUTURE; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VCP215H
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Needle broke on suture end of needle.Needle was not retained in patient.Lot was pulled from use.Fda safety report id# (b)(4).

• Brand Name: 3-0 VICRYL PLUS RB-1 SUTURE
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 13141975
• Report Number: MW5106407
• Device Sequence Number: 14599663
• Product Code: GAM
• UDI-Device Identifier: 10705031051683
• UDI-Public: (01)10705031051683
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: VCP215H
• Device Catalogue Number: VCP215H
• Device Lot Number: RJMJUL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Unknown