MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LIMITORR VOLUME EVD 20ML; N/A

Catalog Number INS9020SP1

Device Problem Break (1069)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.A photo was provided demonstrating the failure and device lot number.The device history records were reviewed and no anomaly was reported during the manufacturing and packaging processes that can be associated to the reported condition.The lot complied with all in-process inspections and testing requirements as specified in the manufacturing shop order and related procedures.The complaint was confirmed.The reported condition was consistent with previous complaints received for stopcock breakage at the transducer connection.The most probable root cause has been identified to be related to the stopcock supplier.(b)(4).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, 2648988-2019-00042, 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, 2648988-2019-00064, 2648988-2019-00065, 2648988-2019-00066, 2648988-2019-00067, 2648988-2019-00068, 2648988-2019-00069.

Event Description

This is 9 of 28 reports.A customer reported that a patient's external ventricular drain (ins9020sp1 limitorr volume evd 20ml) broke at the transducer hub, unwitnessed.The evd was clamped and intact at that time and patient was laying flat.The break likely occurred during lying of head of bed (hob) flat to boost the patient up in the bed.Upon raising the hob, the transducer was noted to be leaking cerebrospinal fluid (csf) and found to be broken.The nurse clamped immediately and replaced within 10 minutes.The date of the event was reported as (b)(6) 2018.

• Brand Name: LIMITORR VOLUME EVD 20ML
• 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: 8738984
• MDR Text Key: 149335860
• Report Number: 2648988-2019-00050
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: INS9020SP1
• Device Lot Number: 2785791
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/27/2019
• Date Device Manufactured: 04/12/2018
• 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
• Treatment: TRANSDUCER