MAUDE Adverse Event Report: BD BD PLASTIPAK 3 ML SYRINGE; SYRINGE, PISTON

Lot Number 1187686

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2022

Event Type  malfunction  

Event Description

[evusheld] use for covid-19 under emergency use authorization (eua): administered tixagevimab to right ventrogluteal site.While administering this dose, noted small amount of fluid leaking from syringe and needle.Once injection complete- reviewed that needle was tightly secured- was not loose.Able to approx., that at least half of dose was received.Notified facility pharmacist.No further action needed.Pt tolerated both injections well and no reaction was noted in the 1 hour waiting period.Fda safety report id# (b)(4).

• Brand Name: BD PLASTIPAK 3 ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 13366224
• MDR Text Key: 284681423
• Report Number: MW5107000
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1187686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Hispanic