MAUDE Adverse Event Report: RAYNHAM CEREBROFLO EVD CATHETER KIT ¿ 5 KIT CARTON; NEURO

Catalog Number 37550501

Device Problem Disconnection (1171)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported the cerebroflo evd catheter kept on disconnecting form the trocar after tunneled under the scalp.The physician tried several times, even using a suture-tie on the end to try it to the trocar, but still failed and had to fish it out from under the scalp with a hemostat on both sided.Further, after the patient was woken up and back in the icu, one of them came disconnected at the point where the blue catheter connects to the small clear plastic connector.They have to sterilely reconnect it, and a subsequent head ct showed a bunch of intracranial air due to the disconnection.Physician thought these problems come from the cerebroflo being bigger/thicker and stiffer than the bactiseal.

Event Description

N/a.

Manufacturer Narrative

The cerebroflo evd catheter (id (b)(6)) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CEREBROFLO EVD CATHETER KIT ¿ 5 KIT CARTON
• Type of Device: NEURO
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12730356
• MDR Text Key: 279361386
• Report Number: 3014334038-2021-00220
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 37550501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• 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