MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER SAFETY SCALPEL SIZE 21, STERILE

Model Number 372621

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2016

Event Type  malfunction  

Event Description

The issue reported was for a scalpel blade protruding through the sterile packaging when the item was being stocked, a potential laceration issue (safety).

• Brand Name: BARD-PARKER SAFETY SCALPEL SIZE 21, STERILE
• Type of Device: BARD-PARKER SAFETY SCALPEL SIZE 21, STERILE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer Contact: bradley liske ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 5484309
• MDR Text Key: 39818359
• Report Number: 1836161-2016-00018
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 372621
• Device Lot Number: 0065160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1