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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD WHITACRE¿ SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE
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BECTON DICKINSON, S.A. BD WHITACRE¿ SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 405076
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2023
Event Type  malfunction  
Event Description
It was reported that 1 bd whitacre¿ spinal needle each from lots 2203009 and 2204007 leaked medication between the needle and syringe during use.The following information was provided by the initial reporter, translated from spanish: "during use.Drug leakage.The pharmacy informs us that anaesthetists comment that there is usually a leakage of medication between the cone of the syringe and the needle (they assume that the needle is correctly positioned in the cone).".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2203009.Medical device expiration date: 28-feb-2027.Device manufacture date: 14-mar-2022.Medical device lot #: 2204007.Medical device expiration date: 31-mar-2027.Device manufacture date: 20-apr-2022.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 1 bd whitacre¿ spinal needle each from lots 2203009 and 2204007 leaked medication between the needle and syringe during use.The following information was provided by the initial reporter, translated from spanish: "during use.Drug leakage.The pharmacy informs us that anaesthetists comment that there is usually a leakage of medication between the cone of the syringe and the needle (they assume that the needle is correctly positioned in the cone).".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 28-feb-2023.H6: investigation summary twenty five samples of lot 2203009 along with twenty one sample of lot 2204007 were provided to our quality team for investigation.The products were visually inspected, no damage or defects were observed on any of the product.Drip testing was performed, the samples were connected to the appropriate luer fitting, all connections were secure, and no leakage occurred.The needle was then connected to a syringe and additional leakage testing was conducted, in all cases liquid passed from the syringe through the needle as intended and no leakage was identified.Product undergoes visual and functional testing throughout manufacturing to ensure the quality of the device, including verification that all critical dimensions are within specification.The returned samples were measured and verified all luer dimensions were within specification.A device history review was performed for lots 2203009 and 2204007, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on our investigation, a root cause related to our manufacturing process could not be identified.It was indicated the syringe used with the device was a luer slip tip.It was determined the root cause was the syringe used with the needle, a luer lock syringe is recommended to ensure proper connection of the hub as a slip tip does not properly engage with the device.
 
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Brand Name
BD WHITACRE¿ SPINAL NEEDLE
Type of Device
ANESTHESIA CONDUCTION NEEDLE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16390396
MDR Text Key309944665
Report Number3003152976-2023-00027
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number405076
Device Lot NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2023
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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