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

Model Number M8726

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  malfunction  

Event Description

Doctor went to use an ethicon prolene® polypropylene 6-0 suture on a c-1 needle (ref (b)(4) and noted that the 6-0 suture was split and unraveling.This stitch was removed and a new prolene® polypropylene suture was used to continue sewing the saphenous vein on the heart.

• Brand Name: PROLENE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON, LLC; 475 c street; los frailes industrial park, suite 401; guaynabo PR 00969
• MDR Report Key: 16311231
• MDR Text Key: 308944567
• Report Number: 16311231
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2023,01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8726
• Device Catalogue Number: M8726
• Device Lot Number: RLBBQE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Male
• Patient Weight: 89 KG