MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION NITROGLYCERIN SET WITH DUO-VENT SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	1C8043
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility submitted medwatch (b)(4) for this event.Mfr site: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the luer lock on the end of a nitroglycerin set would not screw down onto the male adapter of an unspecified saline lock.This was identified during set up.A clamp was used to loosen the fitting (collar); however, the fitting did not loosen.A new set was used with no further issues.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NITROGLYCERIN SET WITH DUO-VENT SPIKE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16314803
• Report Number: 1416980-2023-00357
• Device Sequence Number: 17724008
• Product Code: FPA
• UDI-Device Identifier: 00085412019994
• UDI-Public: (01)00085412019994
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K150860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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 Catalogue Number: 1C8043
• Device Lot Number: R21D26044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/14/2023
• Date Device Manufactured: 04/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown