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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP; PISTON SYRINGE Back to Search Results
Catalog Number 302995
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 2 bd syringe luer-lok¿ tips experienced foreign matter in device cannula/needle/syringe or any fluid path component.The following information was provided by the initial reporter: material no: 302995, batch no: 0255388.Upon opening there was a milky substance in the syringe tip.Other syringes had a black shiny "bit ' looks like it had melted.
 
Manufacturer Narrative
H.6.Investigation: two photos each displaying a single loose 10ml syringe were received and evaluated.It was unclear if the syringe was manipulated.There appeared to be a white foreign matter substance attached to the stopper in the fluid path.The composition of the foreign matter could not be determined based on the photos.Potential root cause for the foreign matter defect could not be determined based on the photos provided.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.
 
Event Description
It was reported that 2 bd syringe luer-lok¿ tips experienced foreign matter in device cannula/needle/syringe or any fluid path component.The following information was provided by the initial reporter: material no: 302995, batch no: 0255388.Upon opening there was a milky substance in the syringe tip.Other syringes had a black shiny "bit ' looks like it had melted.
 
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Brand Name
BD SYRINGE LUER-LOK TIP
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key11388343
MDR Text Key233996624
Report Number1213809-2021-00110
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302995
Device Lot Number0255388
Was Device Available for Evaluation? No
Date Manufacturer Received03/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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