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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP

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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP Back to Search Results
Catalog Number 301029
Device Problems Break (1069); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2018
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. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7088988; medical device expiration date: 2022-03-31; device manufacture date: 2017-03-29. Medical device lot #: 7088992; medical device expiration date: 2022-04-30; device manufacture date: 2017-03-29. Medical device lot #: 7178880; medical device expiration date: 2022-06-30; device manufacture date: 2017-06-27. Medical device lot #: 7237636; medical device expiration date: 2022-07-31; device manufacture date: 2017-08-25. Medical device lot #: 7277752; medical device expiration date: 2022-09-30; device manufacture date: 2017-10-04.
 
Event Description
It was reported that before use a bd syringe luer-lok¿ tip was found with multiple malfunctions. Foreign matter, excess lubricant, volumetric issues, inclusions and damage. There was no report of exposure, injury or medical intervention needed.
 
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Brand NameBD SYRINGE LUER-LOK¿ TIP
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7621848
MDR Text Key112442294
Report Number1213809-2018-00377
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301029
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/20/2018 Patient Sequence Number: 1
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