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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILTER NEEDLE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILTER NEEDLE Back to Search Results
Catalog Number 305211
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/15/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd¿ blunt filter needle had foreign matter on the needle tip.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: when removed the cap, fm like dust was on the needle tip.Replaced by new product.Lot# is 7236772 or 7236779.
 
Manufacturer Narrative
The following fields have been updated with corrections: multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7236772; medical device expiration date: 2022-10-31; device manufacture date: 2017-08-24.Medical device lot #: 7236779; medical device expiration date: 2022-10-31; device manufacture date: 2017-08-24305211.
 
Event Description
It was reported that bd¿ blunt filter needle had foreign matter on the needle tip.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: when removed the cap, fm like dust was on the needle tip.Replaced by new product.Lot# is 7236772 or 7236779.
 
Manufacturer Narrative
Investigation: one (1) sample and six (6) photographs were received from the customer for investigation.The sample was viewed using 10x magnification and drops of lubrication were observed on the needle but no foreign matter (fm) was observed.Two (2) of the photos show the shielded needle in the needle shield.Two (2) of the photos show the needle removed from the needle shield.One (1) of the photos shows what appears to be small foreign matter particles on the needle.When the sample was viewed using 10x magnification these were found to be drops of lubrication on the needle but no foreign matter (fm) was observed.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
 
Event Description
It was reported that bd¿ blunt filter needle had foreign matter on the needle tip.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: when removed the cap, fm like dust was on the needle tip.Replaced by new product.Lot# is 7236772 or 7236779.
 
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Brand Name
BD¿ BLUNT FILTER NEEDLE
Type of Device
FILTER NEEDLE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key8566219
MDR Text Key144457045
Report Number1911916-2019-00423
Device Sequence Number1
Product Code FPB
UDI-Device Identifier30382903052111
UDI-Public30382903052111
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 05/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2022
Device Catalogue Number305211
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2019
Date Manufacturer Received04/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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