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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD 1ML BD SYRINGE
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BD 1ML BD SYRINGE Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2015
Event Type  malfunction  
Event Description
Red particles observed in barrel of 1ml bd syringe.Red particles are not physically detectable on the outside or inside of the barrel of the syringe.They appear to be in the plastic.Potential lot numbers recorded internally.Exact lot number unk as packaging was discarded upon use; (b)(4).
 
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Brand Name
1ML BD SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BD
MDR Report Key5207833
MDR Text Key30698146
Report NumberMW5057728
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 11/03/2015
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 No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/03/2015
Type of Device Usage N
Patient Sequence Number1
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