• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP PISTON SYRINGE Back to Search Results
Catalog Number 309657
Device Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
Event Type  malfunction  
Manufacturer Narrative
There are multiple 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. Initial reporter: address unavailable. (b)(6) address used. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined. Also, 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: lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. 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. Based on no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failures. Root cause description: no root cause can be determined as no samples were received. Rationale: capa is not required at this time.
 
Event Description
It was reported that the customer was unable to push on the plunger of the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip to dispense insulin. There was no report of exposure, injury, or medical intervention noted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
Type of DevicePISTON SYRINGE
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 Key7671633
MDR Text Key113744309
Report Number2243072-2018-00464
Device Sequence Number1
Product Code FMF
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 distributor,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309657
Device Lot NumberUNKNOWN
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 Received06/20/2018
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: 07/09/2018 Patient Sequence Number: 1
-
-