MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC NOT APPLICABLE; HEPARIN LOCK FLUSH SOLUTION, USP

Catalog Number 504901

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

Quality assurance initial impact assessment: batch 6028094 is not in the stability program, however, the batch on stability for product code 504901 continues to meet specifications at each test station including assay testing.Final investigation report status: in progress and will be provided in a follow-up to this mdr.

Event Description

May have been a lack of effect (lack of drug effect, drug ineffective) picc [peripherally inserted central catheter] lines clotted (vascular device occlusion, vascular device occlusion) two neonatal patients were administered the product (off label use in unapproved age group, off label use) country of occurrence: united states of america.Internal case reference number fk202312491 is a spontaneous case received on 08-aug-2023 from a health professional that refers to a neonatal patient (patient 2), in which age, gender, and weight were not reported.Patient's medical history was not reported.Concomitant medications were not reported.On an unknown date in 2023 (over the last several weeks), the patient received heparin lock flush solution (ndc 63323-549-01, lot 6028094 with expiry jul-2024, concentration: 100 usp units/ml, strength: 100 usp units, route: iv via picc line) to prevent clotting.On an unknown date in 2023 (over the last several weeks), the patient was administered the product (off label use) and there may have been a lack of effect as their picc line clotted.Action taken with the suspect drug heparin lock flush solution was unknown.Relevant tests/laboratory data were not provided.On an unknown date, outcome was unknown for events of off label use and there may have been a lack of effect as their picc line clotted.The case was considered serious.---- pharmacovigilance assessment: as per uspi of heparin, event drug ineffective was listed while events off label use, vascular device occlusion were unlisted.Considering nature of event, causality of event off label use could not be assessed.In view of lack of information regarding action taken with heparin, onset date and outcome of event vascular device occlusion, causal role of heparin for event vascular device occlusion could not be ascertained.

Manufacturer Narrative

Follow-up #1: final investigation report - investigation findings: no manufacturing issues were identified that would have led to the current complaint.Formulation documentation was reviewed, and all requirements were met for mass and volume measurements, mixing times, temperatures, and ph adjustments.No anomalies were identified in the formulation or filling process documentation that would cause or contribute to the subject complaint.Representative reserve samples were tested for assay and the results were within specification of 99.9% (limit 90.0 - 120.0%).No trend is associated with this complaint.

Event Description

Follow-up #1: final investigation report - investigation findings: no manufacturing issues were identified that would have led to the current complaint.Formulation documentation was reviewed, and all requirements were met for mass and volume measurements, mixing times, temperatures, and ph adjustments.No anomalies were identified in the formulation or filling process documentation that would cause or contribute to the subject complaint.Representative reserve samples were tested for assay and the results were within specification of 99.9% (limit 90.0 - 120.0%).No trend is associated with this complaint.

• Brand Name: NOT APPLICABLE
• Type of Device: HEPARIN LOCK FLUSH SOLUTION, USP
• Manufacturer (Section D): FRESENIUS KABI USA, LLC; us vigilance department; three corporate drive; lake zurich IL 60047
• Manufacturer (Section G): FRESENIUS KABI USA, LLC; 3159 staley rd; grand island NY 14072
• Manufacturer Contact: three corporate drive; three corporate drive; lake zurich, IL 60047
• MDR Report Key: 17713099
• MDR Text Key: 322991451
• Report Number: 1321116-2023-00002
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K092938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 504901
• Device Lot Number: 6028094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CONCOMITANT MEDICATIONS WERE NOT REPORTED
• Patient Outcome(s): Other; Required Intervention