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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE; SYRINGE WITH NEEDLE
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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE; SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 309644
Date of Event 04/18/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.Investigation results: summary: three assembled 10ml luer-lok 20g syringes with needles were received and confirmed to be from batch # 7302859 (p/n 309644).The samples were visually evaluated.The sealed syringe was found with no observed defect, however the 2 loose syringes were found to have twisted hubs.No bent needle defect was observed in the samples received.Damaged hub is a rejectable condition per product specification, therefore damaged hub defect confirmed based on sample evaluation.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.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.Conclusion: sample evaluation: total 3 assembled 10ml luer-lok 20g syringes with needles were received and confirmed to be from batch # 7302859 (p/n 309644).2 of the 3 were loose, 1 of the 3 was in a sealed package.The samples were visually evaluated.The sealed syringe was found with no observed defect.The 2 loose syringes were found to have twisted hubs.No bent needle defect was observed in the samples received.Damaged hub is a rejectable condition per product specification.Damaged hub defect confirmed based on sample evaluation.Dhr review for batch 7302859 (p/n 309644): manufacturing dates: 11/16/2017 to 11/17/2017.Batch quantity was (b)(4).Assembly and package records were reviewed as part of this dhr review.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7302859 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Root cause: root cause and capa not required based on severity and occurrence level defined for this complaint.
 
Event or Problem Description
It was reported the hubs "yellow connector" were found broken on bd luer-lok¿ syringes with bd precisionglide¿ needles prior to use.There was no report of exposure, serious injury or medical intervention.
 
Additional Manufacturer Narrative
Date received by manufacturer correction.Additional information was received by the consumer.The date received by manufacturer field has been updated to correct date of 04/17/2018.
 
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Brand Name
BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
Common Device Name
SYRINGE WITH NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key7507846
Report Number1213809-2018-00260
Device Sequence Number1813163
Product Code FMF
UDI-Device Identifier30382903096443
UDI-Public30382903096443
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K980987
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other,use
Initial Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date (Section B) 05/16/2018
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Other
Device Catalogue Number309644
Device Lot Number7302859
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2018
Initial Date Received by Manufacturer 04/18/2018
Supplement Date Received by Manufacturer04/17/2018
Initial Report FDA Received Date05/11/2018
Supplement Report FDA Received Date05/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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