MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LIMITORR VOLUME LIMITING EVD 30 ML; N/A

Catalog Number INS9030

Device Problems Break (1069); Crack (1135)

Patient Problem Injury (2348)

Event Date 11/04/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.No dhr review was possible since no lot number is available.The complaint is considered unconfirmed.The root cause for this event is undetermined.Linked to mfg report number: 2648988-2018-00053.

Event Description

This is 2 of 2 reports.This is in regards to the second limitorr.It was initially reported on (b)(6) 2018 by the sales representative on behalf of the customer that there had been a crack at the transducer connection for two separate limitorr devices (specific product ids were not provided) while the device was in use.Additional information was received on (b)(6) 2018 and (b)(6) 2018 indicating that the product ids of the limitorrs were ins9020 and ins9030.There was patient injury and revision/medical intervention was required.Date of the incident was (b)(6) 2018.Sus voluntary event report mw5081208 was received on (b)(6) 2018 that indicated an ins9030 limitorr volume limiting evd 30 ml had a port break off the stopcock on (b)(6) 2018.Serious injury that required intervention was reported.Clarification was received from the sales representative on 14dec2018 that the two limitorr issues reported occurred on the same patient.The first limitorr cracked (exact date unknown) and it was replaced with a second limitorr.Then on (b)(6) 2018, the second limitorr also cracked.

• Brand Name: LIMITORR VOLUME LIMITING EVD 30 ML
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8170003
• MDR Text Key: 130533571
• Report Number: 2648988-2018-00054
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K072929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INS9030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1