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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK 1 ML PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK 1 ML PISTON SYRINGE Back to Search Results
Model Number 309628
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
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. Device manufacture date: unknown. Investigation summary: four photos were received and evaluated. The photos showed a loose 1ml ll syringe in a customer¿s hand. The syringe was partially filled with clear liquid to about 0. 3ml line in one photo and 0. 7ml in three photos. Leakage past stopper was observed in some of the photos. One photo showed what appeared to be distorted/jammed stopper on one side stretched up the barrel past the plunger rod tip. Potential root cause for the leakage past stopper defect is associated with the jammed stopper condition due to an issue during the assembly process. Jammed stopper may not form appropriate seal with the barrel wall and can result in leakage. The lot number is unknown, therefore defective rate cannot be identified. Lot number is required to determine if corrective actions are necessary. No corrective actions will be taken based on the available information. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. 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
Bd luer-lok¿ 1 ml. Material no. : 309628 batch no. : unknown. It was reported that syringes are leaking. Verbatim: 309628 - leakage past stopper.
 
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Brand NameBD LUER-LOK 1 ML
Type of DevicePISTON 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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11823531
MDR Text Key250825496
Report Number1213809-2021-00321
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K941562
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
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309628
Device Catalogue Number309628
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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