MAUDE Adverse Event Report: TAKEDA PHARMACEUTICALS AMERICA, INC. FIRAZYR; SYRINGE, PISTON

Lot Number TFVJ09A15

Device Problems Improper Flow or Infusion (2954); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

A sample has been requested to investigate the issue.

Event Description

Patient reported "i had to take firazyr early this morning.I was only able to inject half of the dose for some reason and then it felt like the plunger was resisting? i have no other doses.".

Manufacturer Narrative

Device issue cannot be confirmed because sample was not returned.Investigation report from vetter (cmo) includes, a query was performed within the vetter quality management system regarding any nonconformities for the affected batch.No deviations and no further complaints were documented.Additionally, the firazyr batches manufactured before and after the impacted batch were included into the query.Based on these results, there is no trend indicated regarding similar complaints for the product firazyr.No possible root cause is present during manufacturing at vetter , no capa was initiated.Based on the results of the conducted investigation, there is no impact on the quality of the impacted batch.Dhl (cmo) also conducted investigation, a root cause was not identified for the reported defect.It is unlikely that a defect of this nature would occur during the packaging process at dhl.This is the only complaint received on this lot related to this defect.No lot trend has been established.

Event Description

Patient reported "i had to take firazyr early this morning.I was only able to inject half of the dose for some reason and then it felt like the plunger was resisting.".

• Brand Name: FIRAZYR
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): TAKEDA PHARMACEUTICALS AMERICA, INC.; lexington 02421
• Manufacturer (Section G): TAKEDA PHARMACEUTICALS U.S.A, INC.; 95 hayden avenue; lexington MA 02421
• Manufacturer Contact: christopher karner
• MDR Report Key: 18727764
• MDR Text Key: 336088591
• Report Number: 2032282-2024-00001
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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
• Device Operator: Lay User/Patient
• Device Lot Number: TFVJ09A15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 02/04/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TAKHZYRO
• Patient Age: 23 YR
• Patient Sex: Female