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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE WITHOUT NEEDLE
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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE WITHOUT NEEDLE Back to Search Results
Catalog Number 301029
Device Problems Break (1069); Loose or Intermittent Connection (1371); Device Markings/Labelling Problem (2911); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2018
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 #: 7150678, medical device expiration date: 2022-05-31, device manufacture date: 2017-05-30.Medical device lot #: 7278957, medical device expiration date: 2022-09-30, device manufacture date: 2017-10-05.Medical device lot #: 7277752, medical device expiration date: 2022-09-30, device manufacture date: 2017-10-04.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 luer-lok¿ tip syringes without needles had issues with foreign matter contaminates, barrel damages, insecure stoppers, and misaligned scale markings.There was no report of exposure, injury, or medical intervention.
 
Event Description
It was reported that the bd luer-lok¿ tip syringes without needles had issues with foreign matter contaminates, barrel damages, insecure stoppers, and misaligned scale markings.There was no report of exposure, 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, 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 numbers that could have contributed to the reported defects.Investigation conclusion: since no samples displaying the reported condition were received a potential root cause could not be defined.Correction: due to an it issue beginning on 7/3/2018, 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 manufacturer: no.
 
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Brand Name
BD LUER-LOK¿ TIP SYRINGE WITHOUT NEEDLE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key7805450
MDR Text Key118096478
Report Number1213809-2018-00553
Device Sequence Number0
Product Code FMF
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301029
Device Lot NumberSEE SECTION H.10.
Date Manufacturer Received08/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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