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

Catalog Number RSM434

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Customer initially reports the needles caps are not preventing a 30 gauge from penetrating it.On (b)(6) 2014 customer reports doctor had finger stick when recapping needle, after drawing up medication, it had penetrated cap.No previous pt contact with needle.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported info.

• Brand Name: UNIVERSAL BLOCK TRAY
• Type of Device: 44TRAYS
• Manufacturer (Section D): INTEGRA PAIN MGMT; salt lake city UT 84104
• Manufacturer Contact: sandra lee ; 315 enterprise dr; 6099366828
• MDR Report Key: 4200038
• MDR Text Key: 4966116
• Report Number: 1722447-2014-00012
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960248
• 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: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• 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: 10/07/2014
• 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