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

Catalog Number	2C8851
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two (2) clearlink system nitroglycerin sets had large amounts of air bubbles in the tubing and leaked fluid from the drip chamber.This was discovered while priming total parenteral nutrition (tpn).There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
G1: device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: four (4) samples were returned for evaluation.Visual inspection of the first sample observed an incorrect assembly of the tubing and the bushing.A pressure test and clear passage test were performed on the first sample, and a leak at the joint of the tubing and the bushing was observed.Visual inspection of the second sample observed a low assembly at the joint of the tubing into the drip chamber.Functional tests which included pressure test, clear passage, and priming tests were performed on the second sample, and a leak at the joint of the tubing and the drip chamber was observed.A visual inspection of the third and fourth samples did not identify any abnormalities that could have contributed to the reported condition.Pressure test and clear passage test were performed on the third and fourth samples, and no defects were observed that could generate leaks.The reported condition was verified for two of the four samples only.The cause of the condition was a manual assembly issue during the manufacturing process.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: CLEARLINK 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: 17854734
• Report Number: 1416980-2023-04965
• Device Sequence Number: 17813248
• Product Code: FPA
• UDI-Device Identifier: 00085412046365
• UDI-Public: (01)00085412046365
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: Health Professional
• Device Catalogue Number: 2C8851
• Device Lot Number: R22I06086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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