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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; NEEDLE, CONDUCTION, ANESTHETIC
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BD CARIBE LTD. BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL; NEEDLE, CONDUCTION, ANESTHETIC Back to Search Results
Model Number 405081
Device Problem Material Discolored (1170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2022
Event Type  malfunction  
Event Description
It was reported that the bd¿ spinal needle with quincke bevel experienced incorrect color on the device.The following information was provided by the initial reporter: color of hub has a dark grey which is usually light gray.The number of cases found 1 box.
 
Manufacturer Narrative
Initial reporter addr1: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 17-jan-2023.H6.Investigation summary: photo samples was provided to our quality team for investigation.The photos display the material information as reported, and the photos comply with the specification to color, however, we are not able to confirm the indicated failures therefore we cannot verify the reported issue.A device history review was performed for the reported lot 2129539 and no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Inspections were performed according to procedure and had satisfactory results, product met required specifications for release.Based on our investigation, we cannot identify a definitive root cause at this time.
 
Event Description
It was reported that the bd¿ spinal needle with quincke bevel experienced incorrect color on the device.The following information was provided by the initial reporter: color of hub has a dark grey which is usually light gray.The number of cases found 1 box.
 
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Brand Name
BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL
Type of Device
NEEDLE, CONDUCTION, ANESTHETIC
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 Key15988149
MDR Text Key305882778
Report Number2618282-2022-00092
Device Sequence Number1
Product Code BSP
UDI-Device Identifier30382904050819
UDI-Public30382904050819
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K091758
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
Report Date 01/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number405081
Device Catalogue Number405081
Device Lot Number2129359
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2022
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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