MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY V. MUELLER NEURO / SPINE SHADOW-LINE T-0101; RETRACTOR, SELF-RETAINING

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 07/31/2018

Event Type  malfunction  

Event Description

During a procedure, a piece of the shadow line frame fell apart while being used for retraction.

• Brand Name: V. MUELLER NEURO / SPINE SHADOW-LINE T-0101
• Type of Device: RETRACTOR, SELF-RETAINING
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 7757383
• MDR Text Key: 116451879
• Report Number: MW5078903
• Device Sequence Number: 1
• Product Code: FFO
• 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: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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
• Patient Age: 51 YR
• Patient Weight: 115