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U.S. Department of Health and Human Services

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

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BD BD SYRINGE BD 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-lok 20 ml syringe ref 302830 with an obvious white particulate within the sterile barrel.It was identified during the preparation of a sterile product the eve of (b)(6) 2021; the prep was discarded and did not reach the patient level.Fda safety report id# (b)(4).
 
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Brand Name
BD SYRINGE BD 20 ML
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key12160945
MDR Text Key261712522
Report NumberMW5102501
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 07/09/2021
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 Model Number302830
Device Catalogue Number302830
Device Lot Number1113439
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/12/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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