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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ QUINCKE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE
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BECTON DICKINSON, S.A. BD¿ QUINCKE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 405257
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2023
Event Type  malfunction  
Event Description
It was reported that the bd¿ quincke spinal needle label had no batch or lot# listed on it.This occurred with 12 needles.The following information was provided by the initial reporter: "batch/lot no and mrp is not printed on spinal needle 25g".
 
Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 19-apr-2023.Photo and samples received by our quality team for investigation.Upon visual evaluation, product information is missing on the packaging label, therefore the incident is confirmed.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.H3 other text : see h10.
 
Event Description
It was reported that the bd¿ quincke spinal needle label had no batch or lot# listed on it.This occurred with 12 needles.The following information was provided by the initial reporter: "batch/lot no and mrp is not printed on spinal needle 25g".
 
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Brand Name
BD¿ QUINCKE 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
8448235433
MDR Report Key16704868
MDR Text Key313564779
Report Number3003152976-2023-00122
Device Sequence Number1
Product Code BSP
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,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/21/2023
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 Number405257
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2023
Initial Date FDA Received04/07/2023
Supplement Dates Manufacturer Received04/21/2023
Supplement Dates FDA Received05/08/2023
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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