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

Lot Number TFVG07A01

Device Problem Improper Flow or Infusion (2954)

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

Event Type  malfunction  

Event Description

Patient advised that she injected yesterday and the injection didn't work.She had 3, so used another which worked.No further information provided.

Manufacturer Narrative

Device issue cannot be confirmed because the sample was not returned to takeda.Investigation report pending from cmo (contract manufacture organization) to provide additional information.

Event Description

Patient advised that she injected yesterday and the injection didn't work.She had 3, so used another which worked.No further information provided.Additional information received: patient mum advised that when she tried using the firazyr but the injection did not go in and had left marks and pricked the skin and advised none of the liquid went in.

Manufacturer Narrative

Device issue cannot be confirmed because sample was not returned.However, cmos performed investigations for the related batch.Based on the risk assessment no impact on the batch quality is given.A clear root cause is not identified.An external cause like a handling error during use or an error with the pen/device cannot be excluded.Additional investigation pending from syringe manufacturer.

Manufacturer Narrative

No sample/photo was provided to syringe manufacturer for analysis.The batch involved in this complaint meets all acceptable quality levels (aql's), was manufactured, and released according to applicable procedures and specifications.A review of the quality history within the sap system has been performed as part of the investigation.No quality notifications, no abnormity and non-conformance were identified during the production which relate to the reported condition.However, the investigation verified complaint history records from the syringe cmo's customer complaint system and concludes that: a 24 months complaint system history search has been performed on same catalogue number and 03 (three) similar complaint (difficult/unable to operate) was reported.Two in may 2022, one in april 2024 however complaints were not confirmed.

Event Description

Patient advised that she injected yesterday and the injection didn't work.She had 3, so used another which worked.No further information provided.Additional information received: patient mum advised that when she tried using the firazyr but the injection did not go in and had left marks and pricked the skin and advised none of the liquid went in.

• Brand Name: FIRAZYR
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): TAKEDA PHARMACEUTICALS AMERICA, INC.; lexington MA 02421
• Manufacturer (Section G): TAKEDA PHARMACEUTICALS U.S.A, INC.; 95 hayden avenue; lexington MA 02421
• Manufacturer Contact: christopher karner ; 95 hayden street; lexington, MA 02421
• MDR Report Key: 18887594
• MDR Text Key: 337743485
• Report Number: 2032282-2024-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2024

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: TFVG07A01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 02/26/2024; 02/26/2024
• Supplement Dates FDA Received: 04/10/2024; 05/07/2024
• 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: 15 YR
• Patient Sex: Female