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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD WHITACRE¿ SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE
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BECTON DICKINSON BD WHITACRE¿ SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 400370
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2023
Event Type  malfunction  
Event Description
It was reported that while using the bd whitacre¿ spinal needle there was foreign matter present.The following was received from the initial reporter: it was reported that a residue was found on the tip of needle after priming.
 
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: one (1) photo was provided by the customer for this investigation.In the photo it is observed an unidentified matter in the tip of the needle.No actual samples were received for this complaint.A device history review was performed for reported lot 3041719, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the investigation the defect was confirmed per evaluation of the photo provided by the customer.However, it¿s source cannot be determined without an actual sample.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
 
Event Description
It was reported that while using the bd whitacre¿ spinal needle there was foreign matter present.The following was received from the initial reporter: it was reported that a residue was found on the tip of needle after priming.
 
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Brand Name
BD WHITACRE¿ SPINAL NEEDLE
Type of Device
ANESTHESIA CONDUCTION NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17880820
MDR Text Key325255567
Report Number2243072-2023-01799
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Reporter Country CodeAS
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 10/10/2023
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 Number400370
Device Lot Number3041718
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/22/2023
Initial Date FDA Received10/05/2023
Supplement Dates Manufacturer Received10/10/2023
Supplement Dates FDA Received10/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2023
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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