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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL, STERILE, SINGLE USE,; ANESTHESIA CONDUCTION NEEDLE
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BD CARIBE LTD. BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL, STERILE, SINGLE USE,; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Model Number 405180
Device Problem Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date 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¿ spinal needle with quincke bevel, sterile, single use, the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: needles tips were blocked and was unable to inject.
 
Manufacturer Narrative
H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
 
Event Description
It was reported while using bd¿ spinal needle with quincke bevel, sterile, single use, the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: needles tips were blocked and was unable to inject.
 
Event Description
It was reported while using bd¿ spinal needle with quincke bevel, sterile, single use, the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: needles tips were blocked and was unable to inject.
 
Manufacturer Narrative
H6: investigation summary eleven unopened samples received by our quality team for investigation.Upon visual evaluation, no defects or issues observed.Further testing was conducted, needles were not clogged.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
 
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Brand Name
BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL, STERILE, SINGLE USE,
Type of Device
ANESTHESIA CONDUCTION NEEDLE
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer (Section G)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16375670
MDR Text Key309599463
Report Number2618282-2023-00012
Device Sequence Number1
Product Code BSP
UDI-Device Identifier30382904051809
UDI-Public(01)30382904051809
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K210978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/08/2023
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 Model Number405180
Device Catalogue Number405180
Device Lot Number2073452
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/24/2023
Initial Date FDA Received02/14/2023
Supplement Dates Manufacturer Received03/08/2023
05/08/2023
Supplement Dates FDA Received03/21/2023
05/22/2023
Was Device Evaluated by Manufacturer? Yes
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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