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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD MICROLANCE¿ NEEDLES

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BECTON DICKINSON, S.A. BD MICROLANCE¿ NEEDLES Back to Search Results
Catalog Number 304622
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 12/11/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.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 bd microlance¿ needle had a hair on a new hypodermic needle.
 
Manufacturer Narrative
Investigation summary: since no sample neither picture has been provided, we were unable confirm your indicated failure mode, so no root cause was possible to determine at this time.No dhr was performed as the lot number is unknown.
 
Event Description
It was reported that bd microlance¿ needle had a hair on a new hypodermic needle.
 
Manufacturer Narrative
Correction: in section h.10 of the previously submitted mdr, sections d.1 and h.1 were incorrectly referenced as the medical device expiration date and device manufacture date.This supplemental mdr is being submitted to correct those references to show the following: medical device expiration date and device manufacture date.
 
Event Description
It was reported that bd microlance¿ needle had a hair on a new hypodermic needle.
 
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Brand Name
BD MICROLANCE¿ NEEDLES
Type of Device
NEEDLE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
MDR Report Key8204449
MDR Text Key131775284
Report Number3002682307-2018-00336
Device Sequence Number1
Product Code FMF
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,health professional,o
Type of Report Initial,Followup,Followup
Report Date 01/25/2019
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 Catalogue Number304622
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 12/11/2018
Initial Date FDA Received12/28/2018
Supplement Dates Manufacturer Received12/11/2018
12/11/2018
Supplement Dates FDA Received01/17/2019
01/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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