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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 302995
Device Problem Fungus in Device Environment (2316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2019
Event Type  malfunction  
Manufacturer Narrative
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 mold was found inside the bd syringe luer-lok¿ tip and packaging before use.The following information was provided by the initial reporter: "customer stated that the case of 10ml syringes were contaminated due to mold being inside some of the syringes and the box.".
 
Event Description
It was reported that mold was found inside the bd syringe luer-lok¿ tip and packaging before use.The following information was provided by the initial reporter: "customer stated that the case of 10ml syringes were contaminated due to mold being inside some of the syringes and the box.".
 
Manufacturer Narrative
Investigation summary: a broken ripped shelf carton was received, containing sealed packaged 10ml syringes, confirmed to be from batch #9170944 (p/n 302995).Some packages were in strips of 5, while others in 2, 3, or single.The samples were visually evaluated.Several packages were observed to have large quantities of dark green foreign matter primarily on the bottom web.Several packages had trace amounts found on the top web, apparently from contact with the other packages or due to sample handling.The fm appeared to be grease.Two of the packages had bottom web trim sealed on top of the bottom web with grease marks in the trim.The packages with large amounts of fm had seal marks imprinted over the foreign matter.None of the syringes inside the packages exhibited signs of the foreign matter ¿ the fm was only found on the outside of the packages.To confirm the type of fm found, a sample was sent for fourier transform infrared spectroscopy analysis(ftir).Ftir confirmed the foreign matter to likely be grease used in the assembly and packaging machines.Visually, the grease observed matched the kind of grease used in the tooling of the packaging machine.Potential root cause for the grease foreign matter defect is likely due to web trim getting caught in the packaging machine¿s chain.The trim then came in contact with grease used in the tooling underneath the machine and transferred a portion of the grease onto the outside of the bottom web.It is likely the product was not properly contained while the issue was being corrected.Three 10ml syringes were submitted to the microlab for testing.The sda (sabouraud dextrose agaragar) plates were examined for growth on the 7th day of incubation.No visual evidence of growth was present on any of the sda agar plates.Since no evidence of mold growth was observed on any of the agar plates, mold contamination may be ruled out as the contaminant of the three (3), bd 10ml luer-loktm tip syringes of lot#9170944, catalog # 302995.Sampled during this investigation.No corrective actions are necessary based on the defective rate identified.Batch 9170944 is considered in compliance with our product specification requirements.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.H3 other text : see section h.10.
 
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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 Key9224618
MDR Text Key181738926
Report Number1213809-2019-01062
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903029953
UDI-Public30382903029953
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302995
Device Lot Number9170944
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Date Manufacturer Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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