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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD® 10ML SYRINGE NRFIT¿ LOK (STERILE); PISTON SYRINGE WITH NEURAXIAL CONNECTOR
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BECTON DICKINSON MEDICAL SYSTEMS BD® 10ML SYRINGE NRFIT¿ LOK (STERILE); PISTON SYRINGE WITH NEURAXIAL CONNECTOR Back to Search Results
Model Number 400174
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2022
Event Type  malfunction  
Event Description
It was reported while using bd® 10ml syringe nrfit¿ lok (sterile) the tip of the luer was deformed.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: one of our testing sites initially believed the nrfit syringes to be incompatible with the nrfit needles; however upon closer inspection they confirmed the nrfit syringe contained a defect.
 
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this.Initial reporter name and address: address information was not able to be obtained, therefore, (b)(6) was used as a place holder.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® 10ml syringe nrfit¿ lok (sterile) the tip of the luer was deformed.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: one of our testing sites initially believed the nrfit syringes to be incompatible with the nrfit needles; however upon closer inspection they confirmed the nrfit syringe contained a defect.
 
Manufacturer Narrative
H6: investigation summary: one photo was provided to our quality team for investigation.Through visual inspection, it was observed that sample had 10ml luer lock standard barrel instead of 10ml nrfit lock barrel.Potential root cause for the mixed product defect is associated with inadequate line clearance on the marking machinery.A corrective action project was opened to further investigate these defect.Manufacturing personnel will be notified of this incident and additional training will be provided.A device history record review was completed for provided lot number 1041220.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Based on the investigation with the photo analysis the symptom reported is confirmed.
 
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Brand Name
BD® 10ML SYRINGE NRFIT¿ LOK (STERILE)
Type of Device
PISTON SYRINGE WITH NEURAXIAL CONNECTOR
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 Key15498951
MDR Text Key303916094
Report Number1213809-2022-00649
Device Sequence Number1
Product Code QEH
UDI-Device Identifier00382904001742
UDI-Public00382904001742
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192538
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 10/12/2022
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 Model Number400174
Device Catalogue Number400174
Device Lot Number1041220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/08/2022
Initial Date FDA Received09/28/2022
Supplement Dates Manufacturer Received10/12/2022
Supplement Dates FDA Received10/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2021
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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