MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER DISPOSABLE SCALPELS SIZE 15, NON-STERILE

Model Number 371633

Device Problem Break (1069)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported the physician was putting in a chest tube in a patient and the blade broke.The patient was injured and had to go to surgery to remove the blade.

• Brand Name: BARD-PARKER DISPOSABLE SCALPELS SIZE 15, NON-STERILE
• Type of Device: BARD-PARKER DISPOSABLE SCALPELS SIZE 15
• 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: 6228282
• MDR Text Key: 64511787
• Report Number: 1836161-2017-00001
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 371633
• Device Lot Number: 0111051
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention