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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD MICROLANCE¿ 3 NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON, S.A. BD MICROLANCE¿ 3 NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 304000
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2019
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 bd microlance¿ 3 needle broke off from the syringe during use when pressing the plunger.The following information was provided by the initial reporter: "when the patient push the plunger the needle disengaged from the syringe and he couldn't perform his injection.".
 
Manufacturer Narrative
Investigation summary bd has not been provided with photos or samples for catalog 304000 lot 180403 to investigate for this record.Microlance needles g30 were assembled with the caverjet syringe that simulated the manipulation the customer where the positioning of the hub in the syringe tip with a slightly rotational movement.None of the retained syringes examined presented the reported defect and the hub fit perfectly with the syringe tip.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.Bd understands a defective hub connection issue took place.This issue could occur because of a defective connectivity due to a defective luer dimensions or any damaged in the syringe tip.It could be also related with the handling of the product as some insufficient adjustment between of the devices.Device history review was done and no abnormalities or issues were identified.No corrective actions are required at this time.
 
Event Description
It was reported that the bd microlance¿ 3 needle broke off from the syringe during use when pressing the plunger.The following information was provided by the initial reporter: "when the patient push the plunger the needle disengaged from the syringe and he couldn't perform his injection.".
 
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Brand Name
BD MICROLANCE¿ 3 NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
MDR Report Key9526013
MDR Text Key192177606
Report Number3002682307-2019-00690
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 01/23/2020
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 Lay User/Patient
Device Expiration Date03/31/2023
Device Catalogue Number304000
Device Lot Number180403
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/11/2019
Initial Date FDA Received12/27/2019
Supplement Dates Manufacturer Received12/11/2019
Supplement Dates FDA Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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