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

Lot Number	NGFA130921
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2124215-2024-15265
• Device Sequence Number: 7042439
• Product Code: DXF
• UDI-Device Identifier: 00685447000211
• UDI-Public: 00685447000211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/13/2024
• Device Lot Number: NGFA130921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown