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

Catalog Number 10-110

Device Problems Break (1069); Crack (1135); Leak/Splash (1354)

Patient Problems Cerebrospinal Fluid Leakage (1772); Injury (2348)

Event Date 12/16/2018

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfr.Report number: 2648988-2019-00013, 2648988-2019-00014, 2648988-2019-00016, 2648988-2019-00017.

Event Description

This is 3 of 5 reports.A risk management specialist reported that a 10110 csf drainage system was cracked on (b)(6) 2018.Additional information received on 06feb2019 indicating that the connecting part of the transducer and the external ventricular drain (evd) port snapped off.There was no patient injury reported.However, the external part of the drain needed to be changed by the neuro surgeon.Additional information has been requested.

Manufacturer Narrative

The complaint unit was not returned for evaluation.No dhr review was possible since no lot number was reported.No samples were received for failure analysis.The complaint could not be confirmed.No further evaluation is possible at this moment and therefore, the root cause for this event is undetermined.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Additional information received on 04jun2019 in a medwatch form (uf/importer report#: (b)(4) with the following information: there were several events related to the external ventricular drains (evd) leaking at the junction where evd was connected to the transducer set up.The evd were then clamped in two places: proximally nearest to the 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.

• 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
• MDR Report Key: 8333202
• MDR Text Key: 135951780
• Report Number: 2648988-2019-00015
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10-110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EDWARDS LIFESCIENCES TRANSDUCER
• Patient Age: 50 YR