MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER; STAINLESS STEEL BLADES SIZE 22, STERILE

Model Number 371222

Device Problems Difficult to Remove (1528); Material Rupture (1546)

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

Event Date 06/17/2014

Event Type  malfunction  

Event Description

Customer states the product has become a safety issue because they cannot remove the blade 371222 from the handles 371060 that have been used forever for this product.It has become a safety issue as one exploded in a team member's face when he was trying to remove the blade.Fortunately, he was wearing a face mask and was protected.

• Brand Name: BARD-PARKER
• Type of Device: STAINLESS STEEL BLADES SIZE 22, STERILE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI
• Manufacturer Contact: 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 4003226
• MDR Text Key: 4775462
• Report Number: 1836161-2014-00038
• Device Sequence Number: 1
• Product Code: MDM
• 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: 06/27/2014

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: Health Professional
• Device Model Number: 371222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2014
• Initial Date FDA Received: 06/27/2014
• 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