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

Catalog Number	1C8043
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported this event to the fda through medwatch (b)(4).(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) vented nitroglycerin sets broke during priming, leading to a leak.When the nurse hung the bag for the first set, there was saline leaking from the line and the nurse noticed that the set was broken.The set was replaced with a new set, the new set was primed, and the same section of the second set also broke and leaked.A third set was then prepared, and no issues or breaks were noted with the third set.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 - CARTAGO; cartago
• MDR Report Key: 8363242
• Report Number: 1416980-2019-01013
• Device Sequence Number: 1994824
• Product Code: FPA
• UDI-Device Identifier: 00085412019994
• UDI-Public: (01)00085412019994
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K150860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: Health Professional
• Device Expiration Date: 03/02/2023
• Device Catalogue Number: 1C8043
• Device Lot Number: R18C02182
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1