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

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Device issue cannot be confirmed because sample was not returned to takeda.Investigation report pending from contract manufacturing organization for additional information.

Event Description

Pharmacist noted that a patient found a leakage from firazyr 30mg pfs (1 unit) while attempting to administer it at her home on (b)(6) 2024.Patient was only able to receive the half dose on the day.

Event Description

Pharmacist noted that a female patient in her 40s found a leakage from firazyr 30mg pfs (1 unit) while attempting to administer it at her home on (b)(6) 2024.Patient was only able to receive the half dose on the day.

Manufacturer Narrative

Device issue cannot be confirmed because sample was not returned.As no batch was known for this case, no review of documents could be performed and no trend regarding closed complaints for the affected product.As no sample or photo was provided to the cmo of syringe for analysis, the cmo cannot delve deeper into the investigation.However the cmo performed a trend analysis for the same.A 24 months complaint trackwise system history search has been performed on same catalogue number and 01 (one) similar complaint for (leakage) for the affected sku (b)(4) in dec 2022 was reported.However, complaints were not confirmed.A 24 months complaint trackwise system history search has been performed on same reported condition (leakage), there are 02 (two) complaints for leakage complaint for other hypoint sku 300255 (b)(4) in (b)(6) 2022 and (b)(4).Both in (b)(6) 2022 reported.However, complaints were not confirmed.

• Brand Name: FIRAZYR
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): TAKEDA PHARMACEUTICALS AMERICA, INC.; 95 hayden avenue; lexington MA 02421
• Manufacturer (Section G): TAKEDA PHARMACEUTICALS U.S.A, INC.; 95 hayden avenue; lexington MA 02421
• Manufacturer Contact: christopher karner ; 95 hayden avenue; lexington, MA 02421
• MDR Report Key: 18962853
• MDR Text Key: 339023640
• Report Number: 2032282-2024-00004
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female