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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE Back to Search Results
Model Number 309658
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter email: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported when using the bd plastipak¿ luer-lok¿ tip syringe there was liquid/moisture/droplets in the syringe.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "small droplets were detected above the piston of the 3 ml syringe used to sample cells for numeration.".
 
Event Description
It was reported when using the bd plastipak¿ luer-lok¿ tip syringe there was liquid/moisture/droplets in the syringe.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "small droplets were detected above the piston of the 3 ml syringe used to sample cells for numeration.".
 
Manufacturer Narrative
H.6.Investigation: twelve photos and one loose 3ml syringe (p/n 309658) was received.The sample was visually evaluated and functionally tested.Brown fluid was observed present behind the stopper seal prior to decontamination.Leakage past stopper testing was performed and yielded acceptable results with no fluid being present beyond the stopper ribs.The syringe barrel from mold c-237 cavity 23 was measured for inside diameter and retaining ring inside diameter with acceptable results.Additionally, the stopper and plunger rod were inspected for any visible defects with none noted.It is unclear how the syringe was used by the customer that may have resulted in fluid leaking past the stopper seal.All barrel dimensions and visual characteristics on syringe components that could contribute to a leakage past stopper defect were evaluated for on the complaint syringe.No non-conforming aspects were found per the sample evaluation and measurements fell within product specification.Depending on how much pressure is put on the plunger rod, and if the plunger is drawn up to the retaining ring it is possible for leakage to occur with this type of user error.However, this cannot be confirmed based on information available.Potential root cause could not be established.The reported defect could not be replicated in the sample received.Since the defect could not be confirmed to have originated via a manufacturing related process and passed internal functional testing and measurements no corrective action is required.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.
 
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Brand Name
BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE
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 Key12800120
MDR Text Key285715931
Report Number1213809-2021-00762
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096580
UDI-Public30382903096580
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2022
Device Model Number309658
Device Catalogue Number309658
Device Lot Number7194537
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2017
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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