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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE Back to Search Results
Catalog Number 309604
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. 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 the stopper separated from the plunger rod on a 10 ml bd luer-lok¿ tip syringe. There was no exposure, injury or medical interventions reported.
 
Manufacturer Narrative
Investigation summary: sample evaluation: one loose 10ml syringe received at bd (b)(4), from unknown batch number, (p/n 309604). Sample was visually evaluated. Distorted stopper was observed on the syringe, this is a rejectable condition per product specification. Based on sample evaluation, product defect is confirmed. Lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Confirmed: bd was able to confirm the customer¿s indicated failure. No root cause can be determined.
 
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Brand NameBD LUER-LOK¿ TIP SYRINGE
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 Key7342176
MDR Text Key102627474
Report Number1213809-2018-00129
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096047
UDI-Public30382903096047
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309604
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2018
Was Device Evaluated by Manufacturer? Yes
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: 03/15/2018 Patient Sequence Number: 1
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