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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; SAFETY SYRINGE WITH NEEDLE
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; SAFETY SYRINGE WITH NEEDLE Back to Search Results
Catalog Number UNKNOWN
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 03/29/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Mckesson medical surgical is the assembler of the ancillary convenience kit to support the u.S.Government's covid-19 vaccination program.We previously reported this event to both (b)(4) but recognize due to a retrospective review that this event should have also been reported as an mdr to fda.As part of our continuous improvement goals we are providing this mdr for review.
 
Event or Problem Description
The customer reported patient saw liquid running down her arm immediately after injection of second dose covid-19 vaccine.Patient is not sure if she actually received the second covid-19 vaccine.No information was received regarding any serious injury as a result of this product malfunction.This complaint was initially reported to pfizer and pfizer forwarded to mckesson.
 
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Common Device Name
SAFETY SYRINGE WITH NEEDLE
MDR Report Key12293038
Report Number3017368639-2021-00072
Device Sequence Number3980080
Product Code MEG
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
UNKNOWN
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/26/2021
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
Operator of Device Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/29/2021
Initial Report FDA Received Date08/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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