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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE Back to Search Results
Catalog Number 309646
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
 
Event Description
It was reported that the bd luer-lok syringe had foreign matter.The following information was provided by the initial reporter: "fm on the plunger was advised that it was an oil residue." ref: (b)(4) lot: multiple.Issue: fm on the plunger was advised that it was an oil residue no pt harm.Sample: yes.Date of event: 01mar2024.
 
Event Description
No additional information.
 
Manufacturer Narrative
One hundred and sixteen samples of 5ml luer-lok syringes (p/n - 309646) were received and evaluated.Eight individual bags each containing a bag of sealed packages from a different batch; consisting of 75 samples from batch 0175566, 24 samples from batch 1181080, 4 samples from 7324720, 4 samples from batch 8267569, 3 samples from batch 9344915, 3 samples from batch 7194570, 2 samples from batch 7086527, and 1 sample from batch 6026822.All samples were found to have no oil or excessive silicone defects and acceptable.Ftir analysis testing was performed and confirmed the substance to be silicone used in the manufacturing process.The condition observed is acceptable per product specification.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.Silicone has been in use in this application for over 20 years, with estimated distribution well in excess of 25 billion units.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.The reported defect was not identified in the samples received.Therefore, no corrective action is required at this time.Batches 1181080, 0175566, 9344915 are considered in compliance with our product specification requirements.The syringes from batches, 8267569, 7324720, 7194570, 7086527, and 6026822 have been expired since 09/30/23, 10/31/22.06/30/22, 03/31/22, and 01/31/21 respectively.Bd does not make claims of the efficacy of expired product.A device history record review is not required due to the complaint being for the design of the product and not a true defect.
 
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Brand Name
BD LUER-LOK
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
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key19008422
MDR Text Key339055708
Report Number1213809-2024-00186
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096467
UDI-Public(01)30382903096467
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309646
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received03/29/2024
Supplement Dates Manufacturer Received08/21/2024
Supplement Dates FDA Received08/23/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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