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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD LUER-LOK; SYRINGE, PISTON
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BECTON, DICKINSON AND COMPANY BD LUER-LOK; SYRINGE, PISTON Back to Search Results
Model Number 305064
Device Problem Moisture Damage (1405)
Patient Problem No Information (3190)
Event Date 10/17/2018
Event Type  malfunction  
Event Description
Prior to using a 10ml syringe with included blunt tip needle, the clinician noted moisture inside the syringe at the plunger tip face.Inspection of several other syringes of the same lot number noted moisture inside the syringes.The syringe lot numbers were recorded and sent back to central supply for exchange.Sample syringe sent to biomedical for reporting to mfg.There was also another reported event of moisture in 10ml syringes in another syringe product (medwatch 0533090000-2018-8009).Manufacturer response for 10ml syringe w.Blunt fill needle, bd luer-lok (per site reporter).Central supply in contact with mfg and distributer and is awaiting response.
 
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Brand Name
BD LUER-LOK
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key8008609
MDR Text Key125149695
Report Number8008609
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number305064
Device Catalogue Number305064
Device Lot Number8218675C09
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/22/2018
Event Location Hospital
Date Report to Manufacturer10/26/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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