MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821731C, EDS 3, GEN LL, NO CATHETER

Model Number NT821731C

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Initial report (ref to natus complaint#: (b)(4).Incident was reported on the 11 jan 2021 - during sterile evd bag change, connection between bag and system fell apart into several pieces after cleaned with alcohol and attempted to unscrew.Minimal pressure was used.The drainage bag was still connected to system at this time.Bag was pulled down in order to seperate from system and released easily but the stem of the bag had broken off and lodged into the system tube tip.Provider paged to change out the system.Customer confirms no patient injury.A request has been made for the affected part to be returned for evaluation.

Event Description

During sterile evd bag change, connection between bag and system fell apart into several pieces, after cleaned with alcohol and attempted to unscrew no patient injury.

Event Description

During sterile evd bag change, connection between bag and system fell apart into several pieces, after cleaned with alcohol and attempted to unscrew no patient injury.

Manufacturer Narrative

Follow up report 001 (ref to natus complaint#(b)(4)).08-feb-2021: after the fourth attempt made to confirm if product will be returning, the customer confirmed they will be returning the product within the next couple days.The affected product will be evaluated once it is returned.Acceptable risk associated with thid complaint as per line 4.13 in doc-035405 rev 04 risk analysis spreadsheet.

Manufacturer Narrative

Follow up report 002 (ref to natus complaint #(b)(4)).Based on the customer's description of the product and events, the failed unit is described as part nt821731c not part nt821733.The initial and follow up report 001 gave reference to part nt821733 laser, leveling device.This report now gives reference to part nt821731c eds 3, gen ll, no catheter.Product examination and functional testing: requests were made for product to be returned on (b)(6), (b)(6) and (b)(6), 2021.Customer did not return the product for evaluation.Capa trending review: capa005047 created to address luer connector breakage issues.Complaint trending review: per qms-004442 complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Risk management file review: acceptable risk associated with the complaint as per line 4.13 in doc-035405 rev 04 risk analysis spreadsheet.Dhr review: products met all specifications upon release.Failure confirmed: no investigation result code: san diego|eds products|no return of device for evaluation.Closure rationale: complaint verified, capa initiated or already open.

Event Description

During sterile evd bag change, connection between bag and system fell apart into several pieces, after cleaned with alcohol and attempted to unscrew.No patient injury.

• Brand Name: NT821731C, EDS 3, GEN LL, NO CATHETER
• Type of Device: NT821731C, EDS 3, GEN LL, NO CATHETER
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego, 92121 CA
• MDR Report Key: 11225602
• MDR Text Key: 229656993
• Report Number: 2023988-2021-00001
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: NT821731C
• Device Catalogue Number: NT821731C
• Device Lot Number: 118000422303 OR 118000422293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1