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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE; PISTON SYRINGE
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BECTON DICKINSON UNSPECIFIED BD SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Inappropriate Audible Prompt/Feedback (2280)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that 5 unspecified bd¿ syringes had broken plunger rods, 1 syringe leaked during use, and 1 syringe caused an occlusion alarm while connected to a pump.The following information was provided by the initial reporter: "it was reported via survey response that the clinician encountered leakage, plunger rod broken/damaged and syringe malfunctioned/caused occlusion alarm while on a pump related to luer lok and luer slip tip syringes.".
 
Manufacturer Narrative
Correction: d.3.Medical device manufacturer: franklin lakes, nj.G.2.Manufacturing location: franklin lakes, nj.
 
Event Description
It was reported that 5 unspecified bd¿ syringes had broken plunger rods, 1 syringe leaked during use, and 1 syringe caused an occlusion alarm while connected to a pump.The following information was provided by the initial reporter: "it was reported via survey response that the clinician encountered leakage, plunger rod broken/damaged and syringe malfunctioned/caused occlusion alarm while on a pump related to luer lok and luer slip tip syringes.".
 
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Brand Name
UNSPECIFIED BD SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11286685
MDR Text Key259574075
Report Number2243072-2021-00234
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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