MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM; N/A

Catalog Number 10110

Device Problems Break (1069); Crack (1135)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 03/30/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The device history records showed no anomalies were found to indicate product failure during manufacturing process of the finished good products.No quality event and/or non-conformance was generated for fg lots reported.The complaint could not be confirmed.Nonetheless, the reported condition is consistent with previous complaints received.The most probable root cause has been identified to be related to the stopcock supplier.Udi number: (b)(4).Linked to mfg report number: 2648988-2019-00070, 2648988-2019-00072, 2648988-2019-00073, 2648988-2019-00013, 2648988-2019-00014, 2648988-2019-00015, 2648988-2019-00016, 2648988-2019-00017.

Event Description

This is 2 of 4 reports.A medwatch form with uf/ importer report # (b)(4) was received on 04jun2019 with the following information: there were several events related to the external ventricular drains (evds) leaking at the junction where the evd connects to the transducer set up.The evds were then clamped in two places: proximally nearest patient and distally at the distal stopcock to prevent exposure.The patients were immediately referred to the neuro surgery provider who changed the collection device on all of the patients.The patients did not have any adverse outcomes related to the device failures.Integra evd devices used were ins9030 limitorr volume limiting evd 30 ml (lot number 2919890) and 10110 csf drainage system with pole mount system (lot number 3242571).The customer did not specify which integra device was used on which patient.Additional information was received on (b)(6) 2019 from the customer that all of the evds were cracked and leaking, requiring removal and replacement.One of the patients reported was a (b)(6) male patient with a diagnosis of intracranial hemorrhage.The date of the event occurred on (b)(6) 2019.

• Brand Name: CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM
• 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: 8743607
• MDR Text Key: 149521313
• Report Number: 2648988-2019-00071
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K920156
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 10110
• Device Lot Number: 3242571
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• Date Device Manufactured: 11/12/2018
• 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: EDWARDS LIFESCIENCES TRANSDUCER
• Patient Age: 40 YR