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

Catalog Number	2C7552
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Initial reporter address: initial reporter city: device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a vented nitro set pvc tbg segme leaked from an unspecified location.This was observed during an unspecified process step.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection was performed using the naked eye did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed including clear passage and pressure testing; and the results were satisfactory.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 ; 2242702068
• MDR Report Key: 15199154
• Report Number: 1416980-2022-04159
• Device Sequence Number: 14013110
• Product Code: FPA
• UDI-Device Identifier: 00085412002750
• UDI-Public: (01)00085412002750
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 2C7552
• Device Lot Number: R17H30019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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