MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LIMITORR, UNSPECIFIED; N/A

Catalog Number XXX-LIMITORR

Device Problem Break (1069)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.Device history record review was not possible since no lot number was provided.The complaint could not be confirmed.The reported condition was consistent with previous complaints received.The most probable root cause has been identified to be related to the stopcock supplier.Linked to mfg report numbers: 2648988-2019-00039, 2648988-2019-00020, 2648988-2018-00012, 2648988-2019-00043, 2648988-2019-00044, 2648988-2019-00045, 2648988-2019-00046, 2648988-2019-00047, 2648988-2019-00048, 2648988-2019-00049, 2648988-2019-00050, 2648988-2019-00051, 2648988-2019-00052, 2648988-2019-00053, 2648988-2019-00054, 2648988-2019-00055, 2648988-2019-00056, 2648988-2019-00057, 2648988-2019-00058, 2648988-2019-00059, 2648988-2019-00060, 2648988-2019-00061, 2648988-2019-00062, 2648988-2019-00063, 2648988-2019-00042, 2648988-2019-00065, 2648988-2019-00066, 2648988-2019-00067, 2648988-2019-00068, 2648988-2019-00069.

Event Description

This is 23 of 28 reports.A customer reported that the external ventricular drain (evd - unspecified limitorr) was discovered to be leaking bloody cerebrospinal fluid (csf) on the floor on (b)(6) 2019.Upon close examination, the transducer had sheared off at the manifold.The drainage set was changed out by doctor.Patient neurologically unchanged.

• Brand Name: LIMITORR, UNSPECIFIED
• 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: 8739012
• MDR Text Key: 149342515
• Report Number: 2648988-2019-00064
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-LIMITORR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2019
• 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
• Treatment: TRANSDUCER