MAUDE Adverse Event Report: INTEGRA PAIN MGMT VENTRICULAR BOLT ICP MONITOR KIT W/ CRANIAL ACCESS

Catalog Number 1104HMC

Device Problems Incomplete or Missing Packaging (2312); Device Packaging Compromised (2916)

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

Event Type  malfunction  

Event Description

The nurse in the neuro intensive care unit opened a convenience kit for the physician to use on a pt at the bedside.When they pulled out the contents of the 1104hmc, there was no hm catheter or ventricular drainage system.Instead, there was a parenchymal catheter.The cranial access kit was there, as expected, but it was basically the contents of a 1104bc convenience kit instead of a 1104hmc as it was labeled.This caused a delay in the procedure as they had to go to another unit in the hosp to get a replacement kit.They threw away everything but the unopened cranial access kit.Additional info has been requested.

Manufacturer Narrative

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

• Brand Name: VENTRICULAR BOLT ICP MONITOR KIT W/ CRANIAL ACCESS
• Type of Device: NA
• Manufacturer (Section D): INTEGRA PAIN MGMT; salt lake city UT 84104
• Manufacturer Contact: rowena bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4180726
• MDR Text Key: 21241981
• Report Number: 2023988-2014-00052
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1104HMC
• Device Lot Number: 98816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• 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