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U.S. Department of Health and Human Services

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

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BECTON DICKINSON AND COMPANY BD¿ SYRINGE WITH BD LUER-LOK¿ TIP; PISTON SYRINGE Back to Search Results
Catalog Number 309653
Device Problem Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Fda notified: the initial reporter also notified the fda on 06/25/2018 via medwatch # mw5077814.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 via medwatch that the bd¿ syringe with bd luer-lok¿ tip syringe was found to have excess lubricant.There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.
 
Event Description
It was reported via medwatch that the bd syringe with bd luer-lok tip syringe was found to have excess lubricant.There was no report of exposure, serious injury or medical intervention.
 
Event Description
It was reported via medwatch that the bd¿ syringe with bd luer-lok¿ tip syringe was found to have excess lubricant.There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: 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.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.This is the second complaint for the lot# 8054766 for foreign matter.Additionally, silicone weight testing is performed at the middle and end of every batch.Silicone weight tests for this batch all measured within specification.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.
 
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Brand Name
BD¿ SYRINGE WITH BD LUER-LOK¿ TIP
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
2153 12th avenue
columbus NE 68601
MDR Report Key7698981
MDR Text Key114681863
Report Number1911916-2018-00378
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096535
UDI-Public30382903096535
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2023
Device Catalogue Number309653
Device Lot Number8054766
Initial Date Manufacturer Received 06/25/2018
Initial Date FDA Received07/18/2018
Supplement Dates Manufacturer Received06/25/2018
06/25/2018
Supplement Dates FDA Received08/21/2018
09/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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