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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MCKESSON MEDICAL SURGICAL, INC.; SAFETY SYRINGE WITH NEEDLE

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MCKESSON MEDICAL SURGICAL, INC.; SAFETY SYRINGE WITH NEEDLE Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 09/29/2021
Event Type  malfunction  
Manufacturer Narrative
Mckesson medical surgical is the assembler of a convenience kit on behalf of the sns that includes this safety syringe.The customer did not provide any product identification.We have notified (b)(6) for awareness.
 
Event Description
The customer asked for guidelines for loose syringe resulting in partial dose given to patient.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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Type of Device
SAFETY SYRINGE WITH NEEDLE
Manufacturer (Section G)
MCKESSON MEDICAL SURGICAL, INC.
1125 sycamore road
manteno IL 60950
Manufacturer Contact
jo silverthorne
9954 mayland drive
richmond, VA 23233
8045532278
MDR Report Key12606777
MDR Text Key277394231
Report Number3017368639-2021-00177
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 10/07/2021
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
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/30/2021
Initial Date FDA Received10/11/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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