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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE STERILE, SINGLE USE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE STERILE, SINGLE USE; PISTON SYRINGE Back to Search Results
Catalog Number 309646
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2019
Event Type  malfunction  
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 #: 9015952, medical device expiration date: 2023-12-31, device manufacture date: 2019-01-15.Medical device lot #: 9008870, medical device expiration date: 2023-12-31, device manufacture date: 2019-01-08.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 before use, excessive amounts of lubricant were noticed on the stoppers of the bd luer-lok¿ syringes, sterile, single use, enough to where some of the syringes had a coating of lubricant slide down the interior of the barrel when the plunger was pulled back.Lot #'s 9015952 and 9008870 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot.The following information was provided by the initial reporter: "recently we have noticed a larger than normal film of lubricant material on the plunger stopper of 5 ml and 10 ml luer lock syringes, to the point where some of the syringes had a coating of lubricant down the interior of the barrel, when the plunger was pulled back.Lot numbers of syringes are 9015952 and 9008870 for 5 ml syringe, and 9015693 for 10ml syringe.".
 
Event Description
It was reported that before use, excessive amounts of lubricant were noticed on the stoppers of the bd luer-lok¿ syringes, sterile, single use, enough to where some of the syringes had a coating of lubricant slide down the interior of the barrel when the plunger was pulled back.Lot #'s 9015952 and 9008870 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot.The following information was provided by the initial reporter: "recently we have noticed a larger than normal film of lubricant material on the plunger stopper of 5 ml and 10 ml luer lock syringes, to the point where some of the syringes had a coating of lubricant down the interior of the barrel, when the plunger was pulled back.Lot numbers of syringes are 9015952 and 9008870 for 5 ml syringe, and 9015693 for 10ml syringe.".
 
Manufacturer Narrative
Investigation: 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.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
 
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Brand Name
BD LUER-LOK SYRINGE STERILE, SINGLE USE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8455948
MDR Text Key144987796
Report Number1213809-2019-00380
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096467
UDI-Public30382903096467
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 05/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309646
Device Lot NumberSEE SECTION H.10.
Date Manufacturer Received03/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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