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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD LUER-LOK, BD GLASPAK ANESTHESIA CONDUCTION KIT

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BECTON DICKINSON BD LUER-LOK, BD GLASPAK ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405671
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Event Description
It was reported when using the bd luer-lok, bd glaspak, the device experienced the depth markings missing (inappropriate graduation markings). The following information was provided by the initial reporter. The customer stated: it was reported the marking isn't working. The markings not working when using spinals. I had another one today did the same thing spinal did not set up marcain not working so now i have had 3 in a week. Lot number for all 3 so far has been.
 
Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
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Brand NameBD LUER-LOK, BD GLASPAK
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12921636
MDR Text Key286266025
Report Number2243072-2021-02853
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
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 03/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number405671
Device Catalogue Number405671
Device Lot Number00014909764
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2021
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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