MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE; N/A

Catalog Number SP0214

Device Problem Use of Device Problem (1670)

Patient Problem Brain Injury (2219)

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device will 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.

Event Description

A clinical specialist reported on behalf of the customer that a nurse accidentally instilled antibiotics into the patient's ventricular catheter - accessing it by connecting the intravenous (iv) tubing to the cerebrospinal fluid (csf) access port of the accudrain (sp0214 ins8400 with one foot of proximal patient line) on an unspecified date.The patient did not die due to the event but acquired irreversible brain damage.The patient required emergency intervention.The nurse admitted that she was adamant and realized that it was not a manufacturing problem but had to put a "safety plan" in place.The nurse wanted to know other external ventricular drain (evd) options.The sales representative discussed the specials for accudrain specifically the one that has the csf access port removed.Additional information has been requested.

Manufacturer Narrative

The product was not returned for evaluation.No dhr review and failure analysis was possible since no fg lot number was reported as part of this incident.Therefore, the reported condition is unconfirmed and the root cause is undetermined.

Event Description

N/a.

• Brand Name: INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE
• 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: 7639632
• MDR Text Key: 112413346
• Report Number: 2648988-2018-00032
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP0214
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability