MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. NRG TRANSSEPTAL NEEDLE; CATHETER, SEPTOSTOMY

Lot Number NGFA130921

Device Problems Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

It was reported that an nrg transseptal needle experienced an issue with the label being torn.No patient complications reported.Device and procedure outcome are unknown.Product is expected to return for analysis.

Manufacturer Narrative

The device was returned for analysis.Based on the testing of the returned product, the allegation is not confirmed, as there was no evidence of a torn label.Additionally, through investigation and review of the media provided, there was presence of foreign material and a handle defect.An analysis of the device found that the original packaging was returned with no issues on the label and the sterile seal was found sealed.Upon opening the package, an embedded particulate was found, located next to the plastic tray close to the connector cable.The sterile seal was then opened, and upon closer inspection, the particulate was a flat black mark embedded into the pouch.The particulate does not meet acceptance criteria for loose particulate, and is therefore considered a failure.In addition, a handle defect was also identified on the thread at the proximal end of the hub.The defect was measured, which although it passes the maximum allowable size, it fails the design spec.An initial mdr is required to report investigation results.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Type of Device: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18914426
• MDR Text Key: 337786788
• Report Number: 2124215-2024-15265
• Device Sequence Number: 1
• Product Code: DXF
• UDI-Device Identifier: 00685447000211
• UDI-Public: 00685447000211
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: NGFA130921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1