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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD SAFETYGLIDE / INJECTION NEEDLE SYRINGE SYRINGE, PISTON

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BD BD SAFETYGLIDE / INJECTION NEEDLE SYRINGE SYRINGE, PISTON Back to Search Results
Lot Number 8064678 CAV08
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2021
Event Type  malfunction  
Event Description
Bd safetyglide 3ml 25g x 1 injection needle with bd luer-lok syringe ref 305924 was defective within the package. The rubber black rubber syringe plunger stopper was skewed sideways. The defective was noticed before usage and no harm was done. Fda safety report id # (b)(4).
 
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Brand NameBD SAFETYGLIDE / INJECTION NEEDLE SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key11292958
MDR Text Key230988768
Report NumberMW5099266
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 02/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number8064678 CAV08
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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

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