MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML L/L NO NEEDLE; SYRINGE, PISTON

Lot Number 1056610

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Indication: myositis, sicca syndrome [sjogren]; event: spontaneous; patient reported leakage out of 3 syringes with reference number 1056610, expiration: 02/28/2026.No missed dose; no ade reported; unknown if available for return.No further information known.Used to infuse hizentra at: hizentra 20% (10gm total) 0.2gm/ml infuse 12gm (60ml) subcutaneously every week.Hizentra 20%(2gm total) 0.2gm/ml infuse 12gm (60ml) subcutaneously every week.Reported to (b)(6) by pt/caregiver.

• Brand Name: SYRINGE 50ML L/L NO NEEDLE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 12481606
• MDR Text Key: 272443177
• Report Number: MW5104020
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1056610
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1