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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 SYRINGE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ 1-ML SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 309628
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2023
Event Type  malfunction  
Event Description
It was reported while using bd luer-lok¿ 1-ml syringe the barrel was cracked.There was no report of patient impact.The following information was provided by the initial reporter: per reporter, the supplied syringe had a crack along the body of it that was noticed after the medication was drawn up into the syringe.Syringe did not leak medication however physician opted to not administer medication due to the defect.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd luer-lok¿ 1-ml syringe the barrel was cracked.There was no report of patient impact.The following information was provided by the initial reporter: per reporter, the supplied syringe had a crack along the body of it that was noticed after the medication was drawn up into the syringe.Syringe did not leak medication however physician opted to not administer medication due to the defect.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 23-mar 2023.H6: investigation summary: one sample and three photos were provided to our quality team for investigation.Through visual inspection, it was observed that the sample has two lines extending down the barrel in the scale marking area.The first line extends from 0.1ml grad line to 0.7ml grad line and has a dark white discoloration at the 0.1ml grad line area.The second line starting at the 0.7ml grad line extending down to the flange with a blackish smoky discoloration.The observed barrel crack line is most likely embedded foreign matter.Potential root cause for the embedded foreign matter defect is associated with the molding process.This defect occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.This type of defect is cosmetic and does not pose risk to the customer.A device history record review was completed for provided lot number 9142579.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¿ 1-ML 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
8448235433
MDR Report Key16579878
MDR Text Key312200007
Report Number1213809-2023-00230
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,Followup
Report Date 04/10/2023
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 Expiration Date04/30/2024
Device Catalogue Number309628
Device Lot Number9142579
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2023
Initial Date FDA Received03/20/2023
Supplement Dates Manufacturer Received04/10/2023
Supplement Dates FDA Received04/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2019
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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