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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 07/24/2023
Event Type  malfunction  
Manufacturer Narrative
H3.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 the bd whitacre¿ spinal needle appeared to leak.The following was received by the initial reporter: when injecting the medication, the needle appeared to leak where the metal needle attaches to the plastic hub.The puncture was smooth and uncomplicated, i.E.Needle not bent, no need to apply force or the like.Then i took another needle and this one did not have the same problem.Both needles were from the same batch (lot number).
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 07-aug-2023.Investigation summary: one sample was provided to our quality team for investigation.Liquid was passed through the needle and a leakage was observed between the needle and hub connection, verifying the reported incident.Upon further evaluation it was identified the cannula hub was incomplete, causing the leak that occurred.A device history review was performed for reported lot 2303015, no deviations or non-conformances related to this issue were identified during the manufacturing process.Three retained samples of the same lot were used for additional evaluation.All product was inspected, no issues related to the cannula hub were identified and no leaks occurred during testing.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures, including verification the needle is properly placed and free from any damage.No issues related to this incident were found during these inspections.While we could not identify a direct issue, this incident likely occurred during the molding process, when the polypropylene is injected into the mold to form the hub around the cannula.
 
Event Description
It was reported that the bd whitacre¿ spinal needle appeared to leak.The following was received by the initial reporter: when injecting the medication, the needle appeared to leak where the metal needle attaches to the plastic hub.The puncture was smooth and uncomplicated, i.E.Needle not bent, no need to apply force or the like.Then i took another needle and this one did not have the same problem.Both needles were from the same batch (lot number).
 
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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.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17484463
MDR Text Key320871162
Report Number3003152976-2023-00321
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Reporter Country CodeNL
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 10/11/2023
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 Health Professional
Device Catalogue Number405076
Device Lot Number2303015
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/24/2023
Initial Date FDA Received08/08/2023
Supplement Dates Manufacturer Received10/11/2023
Supplement Dates FDA Received10/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2023
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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