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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 309648
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used. Investigation summary: two photos were received and evaluated. In both pictures four 1ml luer lock syringes (p/n 309648) were shown, three of the syringes had severe skewed or corkscrewed scales, and one syringe did not have any printing present at all. Physical samples are required for a more in-depth observation. The observed defects were non-conforming per product specification. Potential root cause for the scale marking issue defects is associated with the marking process. These conditions are occurring at/below their expected frequency. Therefore, no corrective action is required at this time. Batch #0059908 is considered in compliance with our product specification requirements. Furthermore, 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. 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
It was reported that 4 bd luer-lok¿ syringes had either crooked or missing scale markings. The following information was provided by the initial reporter, translated from (b)(6) to english: "we received a complaint from a customer that a number of syringes were found with missing or crooked scales. ".
 
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Brand NameBD LUER-LOK SYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12339380
MDR Text Key267167651
Report Number1213809-2021-00577
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K941562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309648
Device Lot Number0059908
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 Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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