MAUDE Adverse Event Report: ETHICON, LLC PROLENE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8702
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
One of the needles in the pack was "very blunt" during distal vein graft anastomosis.

• Brand Name: PROLENE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON, LLC; 475 c street los frailes; industrial park, suite 401; guaynabo PR 00969
• MDR Report Key: 25373590
• Report Number: 25373590
• Device Sequence Number: 18794085
• Product Code: GAW
• UDI-Device Identifier: 10705031045774
• UDI-Public: (01)10705031045774
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/01/2026
• Report Date (Section F): 06/01/2026

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: M8702
• Device Catalogue Number: M8702
• Device Lot Number: TPMHAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Date Report Sent to FDA: 06/01/2026