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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD 10 ML SYRINGE SYRINGE, PISTON

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BD BD 10 ML SYRINGE SYRINGE, PISTON Back to Search Results
Model Number #302995
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Insufficient Information (4580)
Event Date 02/01/2022
Event Type  malfunction  
Event Description
Upon withdrawing contents of a vial, particulate matter was seen in the bd 10 ml syringe that was not in the vial prior to withdrawal. Product was discarded. The syringe and overwrap were not saved. No injuries or harm occurred. Did not reach a patient. Fda safety report id # (b)(4).
 
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Brand NameBD 10 ML SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key13479933
MDR Text Key285454944
Report NumberMW5107280
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number#302995
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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