MAUDE Adverse Event Report: ASPEN SURGICAL PUERTO RICO CORP. BARD-PARKER #11 PROTECTED DISPOSABLE SCALPEL; SCALPEL, ONE-PIECE

Device Problem Material Fragmentation (1261)

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

Event Date 04/29/2018

Event Type  malfunction  

Event Description

During an emergent cricothyrotomy a #11 bard-parker protected disposable scalpel tip broke off.The scalpel tip was removed from the patient's neck in the operating room.The blade was not tagged or saved after the event.

• Brand Name: BARD-PARKER #11 PROTECTED DISPOSABLE SCALPEL
• Type of Device: SCALPEL, ONE-PIECE
• Manufacturer (Section D): ASPEN SURGICAL PUERTO RICO CORP.
• MDR Report Key: 7533802
• MDR Text Key: 109103463
• Report Number: MW5077361
• Device Sequence Number: 0
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1