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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD SYRINGE; SYRINGE, PISTON

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BD BD SYRINGE; SYRINGE, PISTON Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  Injury  
Event Description
[moderna vaccine booster] use for covid-19 under emergency use authorization (eua): moderna covid 19 vaccine, pt claimed she got the shot too high in the arm so it injured her arm.Fda safety report id # (b)(4).
 
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Brand Name
BD SYRINGE
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key13560311
MDR Text Key285931804
Report NumberMW5107551
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/15/2022
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? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/17/2022
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite
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