MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT UNIVERSAL BLOCK TRAY; 44TRAYS

Catalog Number RSM434

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/09/2014

Event Type  Other  

Event Description

At the end of the procedure, the doctor performed single handed recapping and the 30g needle went through the sie of the cap.When he was placing the capped needle into the biohazard box doctor's gloved thumb was punctured by the needle.Doctor reports it was a low risk pt as far as bloodborne pathogens are concerned.

Manufacturer Narrative

The device involved in this reported incident is not available for eval.An investigation has been initiated based on the reported info.

• Brand Name: UNIVERSAL BLOCK TRAY
• Type of Device: 44TRAYS
• Manufacturer (Section D): INTEGRA PAIN MANAGEMENT; salt lake city UT 84104
• Manufacturer Contact: sandra lee ; 315 enterprise drive; 6099366828
• MDR Report Key: 4156579
• MDR Text Key: 18932972
• Report Number: 1722447-2014-00011
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RSM434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2014
• 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
• Patient Age: 45 YR