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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD® QUINCKE SPINAL NEEDLES; ANESTHESIA CONDUCTION NEEDLE
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BECTON DICKINSON, S.A. BD® QUINCKE SPINAL NEEDLES; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 394600
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/22/2022
Event Type  malfunction  
Event Description
It was reported that the bd® quincke spinal needles experienced a broken needle.The following information was provided by the initial reporter: gets stuck and has been breaking in the patient's vein.
 
Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Manufacturer Narrative
H6: investigation summary no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.
 
Event Description
It was reported that the bd® quincke spinal needles experienced a broken needle.The following information was provided by the initial reporter: gets stuck and has been breaking in the patient's vein.
 
Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 0006976; d4: medical device expiration date: 31-dec-2022; h4: device manufacture date: 31-jan-2020.H6: investigation summary as no sample was returned, a thorough sample investigation could not be completed.Damages like these on the stopcock housing do not occur in our production process.The appearance of these cracks is typical for cracks that can occur when the product has been used together with lubrication solution or infusion with high ph-value.These solutions can release internal stress in the product.If excessive force is used when connecting and using the product for more than 24 hours, this may cause the material to crack.We recommend referring to the instructions for use, which is enclosed in each box.A device history record review was completed for provided material number 394600, lot 0006976.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.H3 other text : see h10.
 
Event Description
It was reported that the bd® quincke spinal needles experienced a broken needle.The following information was provided by the initial reporter: gets stuck and has been breaking in the patient's vein.
 
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Brand Name
BD® QUINCKE SPINAL NEEDLES
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 Key15920690
MDR Text Key307574283
Report Number3003152976-2022-00542
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Reporter Country CodeNO
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 04/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2022
Device Catalogue Number394600
Device Lot Number0006976
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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