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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL BNS; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL BNS; PISTON SYRINGE Back to Search Results
Catalog Number 301029
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that syringe 10ml ll bns had foreign matter.The following information was provided by the initial reporter: there is oily residue on the outside of the syringes and also on the rubber plunger.
 
Manufacturer Narrative
Investigation summary: two photos and seven loose 10ml syringes (p/n 301029) were received.The samples were visually evaluated.Each syringe was observed to have excessive silicone on the barrel exterior and on the flanges, with all feeling slippery to the touch.Five of the syringes had excessive silicone inside the fluid path.Two syringes had the expected amount of silicone in the fluid path.The conditions observed were non-conforming per product specification.Potential root cause for the excess silicone defect is associated with the assembly process.The batch number is unknown, therefore defective rate cannot be identified.Batch number is required to determine if corrective actions are necessary.No corrective actions taken based on the available information.The batch number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
 
Event Description
It was reported that syringe 10ml ll bns had foreign matter.The following information was provided by the initial reporter: there is oily residue on the outside of the syringes and also on the rubber plunger.
 
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Brand Name
SYRINGE 10ML LL BNS
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12616722
MDR Text Key276237972
Report Number1213809-2021-00709
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301029
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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