MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR CSF DRAINAGE SYSTEM W/BLUE STRIPE TUBING & 1-WAY; N/A

Catalog Number INS8600

Device Problem Disconnection (1171)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

No failure analysis is possible since the unit was not kept by the customer.Dhr review did not reveal any anomaly that could be related 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 is unconfirmed.The root cause for this event is undetermined.(b)(4).

Event Description

A customer reported that the ins8600 csf drainage system w/blue stripe tubing & 1-way was used on (b)(6) 2019 for hydrocephaly on a (b)(6) year old male patient.On an unspecified date, a disconnection of the tubing at the drainage bag level with important leakage was reported.The nurse clamped the tubing but the tubing broke between the patient and clamping.Immediate closure of external ventricular drainage was performed.There was an increase of neurological follow up of the patient.Scanner was done which did not show any immediate consequence to the patient.The drainage system was changed.

• Brand Name: CSF DRAINAGE SYSTEM W/BLUE STRIPE TUBING & 1-WAY
• 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: 8348838
• MDR Text Key: 136477704
• Report Number: 2648988-2019-00021
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K972994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: INS8600
• Device Lot Number: 2977053
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2019
• Date Device Manufactured: 07/14/2018
• 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
• Patient Age: 59 YR