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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE; PISTON SYRINGE Back to Search Results
Catalog Number 302995
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2023
Event Type  malfunction  
Event Description
It was reported while using bd luer-lok¿ syringe sterile, single use the perforation was poor.There was no report of patient impact.The following information was provided by the initial reporter: the perforation on the packaging is not allowing the packages to be separated from the other syringes in the pack.
 
Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 26-apr-2023.Investigation summary four samples and two photos were provided to our quality team for investigation.Through visual inspection, it was observed that the syringe packages are connected to one another about halfway down to the package.One of the packages in each pair is torn at the perforation compromising the seal integrity.Potential root cause for the uncut packages and open seal defects are associated with the packaging process.A device history record review was completed for provided lot number 2313945.
 
Event Description
It was reported while using bd luer-lok¿ syringe sterile, single use the perforation was poor.There was no report of patient impact.The following information was provided by the initial reporter: the perforation on the packaging is not allowing the packages to be separated from the other syringes in the pack.
 
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Brand Name
BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE
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 Key16820935
MDR Text Key314083013
Report Number1213809-2023-00424
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903029952
UDI-Public(01)00382903029952
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
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 05/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302995
Device Lot Number2313945
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2022
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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