MAUDE Adverse Event Report: ASPEN SURGICAL PUERTO RICO CORP. BARD-PARKER; BLADE, SCALPEL

Catalog Number 373915

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 10/20/2014

Event Type  malfunction  

Event Description

Surgical technician was loading a safety blade on a knife handle.The mechanism malfunctioned and the blade went through injuring the technician with a puncture wound.

• Brand Name: BARD-PARKER
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PUERTO RICO CORP.; rd. 183, km. 20.3; las piedras PR 00771
• MDR Report Key: 6069078
• MDR Text Key: 58849440
• Report Number: 6069078
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 373915
• Device Lot Number: 0102833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1