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U.S. Department of Health and Human Services

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

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BECTON DICKINSON BD LUER-LOK¿ TIP SYRINGE Back to Search Results
Catalog Number 309604
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. There are two bd locations where this bd device may have been manufactured. A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Investigation summary: one photo depicting a blisterpack label from a 10ml syringe, lot number unknown (p/n 309604) received at bd. Unable to perform an evaluation based on the photo received, therefore we were unable to fully investigate this incident, thus a root cause could not be determined. Furthermore, the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. We would be very interested in examining product that does not meet your expectations and our quality standards. Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis. Examination of the product involved may provide clarification as to the cause for the reported failure. We appreciate you taking the time to bring this observation to our attention. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: one photo depicting a blisterpack label from a 10ml syringe, lot number unknown (p/n 309604) received at bd. Unable to perform an evaluation based on the photo received. Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. Lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Unconfirmed: bd was not able to confirm the customer¿s indicated failure root cause description: no root cause can be determined based on the photo received. Rationale: capa is not required at this time.
 
Event Description
It was reported that the bd luer-lok¿ tip syringe "did not have a good seal and would not work". Found before use. No reports of serious injury or medical intervention noted.
 
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Brand NameBD LUER-LOK¿ TIP SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7636576
MDR Text Key112446280
Report Number2243072-2018-00418
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2018
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: 06/25/2018 Patient Sequence Number: 1
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