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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. WHITACRE SET 25GA 3.50 IN FOR INDIA; ANESTHESIA CONDUCTION NEEDLE
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BECTON DICKINSON, S.A. WHITACRE SET 25GA 3.50 IN FOR INDIA; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 405129
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 "quincke spinal needle" was found in the whitacre set 25ga 3.50 in for india box before use.This occurred on 50 separate occasions, but the dates are unknown.The following information was provided by the initial reporter: "quincke spinal needle supplied in sealed whitacre box".
 
Manufacturer Narrative
H.6.Investigation: multiple photos were provided to our quality team for investigation.The pictures received displays product from lot 1905017, item 405120 and lot 1903006, item 405127 inside packages that are labeled as lot 1808018, item 405129.Based on the photo, we are able to verify the reported failure.Retained samples of each item and lot number were inspected and all product within the packages was correct.A device history review for reported lot 1808018 did not reveal any annotations or non-conformances during the manufacturing process related to this issue.All lots, 1808018, 1903006, 1905017 were manufactured and sent for sterilization during separate months, never being housed within the facility during the same time.Product undergoes visual inspections prior to release, including verifying the proper product and quantity is within each package.All inspections for these lots were completed according to procedure, no annotations were noted related to the reported incident.Based on the available information we are not able to identify a root cause related to our manufacturing process at this time.
 
Event Description
It was reported that the "quincke spinal needle" was found in the whitacre set 25ga 3.50 in for india box before use.This occurred on 50 separate occasions, but the dates are unknown.The following information was provided by the initial reporter: "quincke spinal needle supplied in sealed whitacre box.".
 
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Brand Name
WHITACRE SET 25GA 3.50 IN FOR INDIA
Type of Device
ANESTHESIA CONDUCTION NEEDLE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key9930500
MDR Text Key195899448
Report Number3003152976-2020-00155
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2023
Device Catalogue Number405129
Device Lot Number1808018
Initial Date Manufacturer Received 03/17/2020
Initial Date FDA Received04/06/2020
Supplement Dates Manufacturer Received03/17/2020
Supplement Dates FDA Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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