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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; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE Back to Search Results
Catalog Number 301029
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem Exposure to Body Fluids (1745)
Event Date 08/16/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7300615, expiration date: 2022-10-31, manufacture date: 2017-10-27.Medical device lot #: 7305508, expiration date: 2022-10-31, manufacture date: 2017-11-01.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 bd syringe luer-lok¿ tip cracked during use and leaked.There was report of exposure to one nurse, where blood came into direct contact with the face and eyes.No protective eyewear was worn.However, there was no report of medical intervention.
 
Event Description
It was reported that the bd syringe luer-lok tip cracked during use and leaked.There was report of exposure to one nurse, where blood came into direct contact with the face and eyes.No protective eyewear was worn.However, there was no report of medical intervention.
 
Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Device history record review showed no rejected inspections or quality issues during the production of the provided two lot number that could have contributed to the reported defect.Investigation conclusion: no root cause can be determined as no samples were received.
 
Event Description
It was reported that the bd syringe luer-lok tip cracked during use and leaked.There was report of exposure to one nurse, where blood came into direct contact with the face and eyes.No protective eyewear was worn.However, there was no report of medical intervention.
 
Manufacturer Narrative
A disassembled 10ml barrel and plunger rod were received in a biohazard container.The components had signs of contamination and use ¿ apparent blood residue and were evaluated through the bag.No luer damage or deformity was observed, but a barrel crack was found extending between bottom of the barrel and 7ml marking outside the scale.No plunger rod defects were observed.Potential root cause for the cracked barrel defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Device history record review showed no rejected inspections or quality issues during the production of the provided two lot number that could have contributed to the reported defect.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.
 
Event Description
It was reported that the bd syringe luer-lok¿ tip cracked during use and leaked.There were 4 occurrences of this event.There was one report of exposure to one nurse, where blood came into direct contact with the face and eyes.No protective eyewear was worn.However, there was no report of medical intervention.
 
Manufacturer Narrative
Correction: describe event or problem: it was reported that the bd syringe luer-lok¿ tip cracked during use and leaked.There were 4 occurrences of this event.There was one report of exposure to one nurse, where blood came into direct contact with the face and eyes.No protective eyewear was worn.However, there was no report of medical intervention.
 
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Brand Name
BD SYRINGE LUER-LOK¿ TIP
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key7848576
MDR Text Key119325353
Report Number1213809-2018-00592
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup,Followup,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number301029
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? No
Date Manufacturer Received08/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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