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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD LUER-LOK TIP SYRINGE; SYRINGE, PISTON

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BD BD LUER-LOK TIP SYRINGE; SYRINGE, PISTON Back to Search Results
Model Number REF 302832
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Black particulate found inside bd 30 ml syringe.Fda safety report id # (b)(4).
 
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Brand Name
BD LUER-LOK TIP SYRINGE
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
BD
franklin lakes NJ 07417
MDR Report Key8837835
MDR Text Key152697962
Report NumberMW5088422
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 07/24/2019
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 Expiration Date04/30/2019
Device Model NumberREF 302832
Device Lot Number9120506
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/26/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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