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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 Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 that 3 bd luer-lok¿ syringes had crooked scale markings.This complaint was created to capture the 4th of 6 related incidents.The following information was provided by the initial reporter, translated from dutch: "crooked scale x 3.".
 
Event Description
It was reported that 3 bd luer-lok¿ syringes had crooked scale markings.This complaint was created to capture the 4th of 6 related incidents.The following information was provided by the initial reporter, translated from dutch: "crooked scale x 3".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 18-jan-2023.H6: investigation summary three samples were received in a separate bag with a claim of crooked scale.After inspection, it was observed that all the three samples had skewed scale greater than 0.05 degree.Potential root cause for skewed scale print defect with the marking process.A device history record review was completed for provided lot number 1331232.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h10.
 
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Brand Name
BD LUER-LOK¿ 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16138684
MDR Text Key308612598
Report Number1213809-2022-01366
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 Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309648
Device Lot Number1331232
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2021
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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