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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD SYRINGE 20 ML SYRINGE, PISTON

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BD BD SYRINGE 20 ML SYRINGE, PISTON Back to Search Results
Model Number 302830
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  Injury  
Event Description
Bd luer-lock 20 ml syringe (manufacturer #(b)(4)) with an obvious white particulate within the sterile barrel. It was identified during the preparation of a sterile product. The preparation was discarded and did not reach the patient level. Fda safety report id# (b)(4).
 
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Brand NameBD SYRINGE 20 ML
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key12160980
MDR Text Key261783078
Report NumberMW5102503
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number302830
Device Catalogue Number302830
Device Lot Number1113439
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/12/2021 Patient Sequence Number: 1
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