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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD® QUINCKE SPINAL NEEDLE 27G; ANESTHESIA CONDUCTION NEEDLE
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BECTON DICKINSON, S.A. BD® QUINCKE SPINAL NEEDLE 27G; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 405127
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2023
Event Type  malfunction  
Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.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® quincke spinal needle 27g the needle broke.There was no report of patient impact.The following information was provided by the initial reporter: purchase dept received spinal 27g in broken condition.
 
Event Description
It was reported while using bd® quincke spinal needle 27g the needle broke.There was no report of patient impact.The following information was provided by the initial reporter: purchase dept received spinal 27g in broken condition.
 
Manufacturer Narrative
H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
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Brand Name
BD® QUINCKE SPINAL NEEDLE 27G
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
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17908699
MDR Text Key325464048
Report Number3003152976-2023-00449
Device Sequence Number1
Product Code BSP
UDI-Device Identifier30382904050796
UDI-Public(01)30382904050796
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
NA
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 10/12/2023
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 Catalogue Number405127
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/26/2023
Initial Date FDA Received10/10/2023
Supplement Dates Manufacturer Received10/12/2023
Supplement Dates FDA Received10/20/2023
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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