MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. BLADE #11; BLADE, SCALPEL

Lot Number X03531

Device Problem Break (1069)

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

Event Date 07/03/2022

Event Type  malfunction  

Event Description

Or reports that a medline #11 blade made with carbon steel snapped into three pieces when the surgical tech was applying the blade to the handle with a needle driver in the normal fashion.

• Brand Name: BLADE #11
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15093649
• MDR Text Key: 296488497
• Report Number: 15093649
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/12/2022

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
• Device Operator: Other
• Device Lot Number: X03531
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1