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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 10ML SYRINGE LUER-LOK TIP; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD 10ML SYRINGE LUER-LOK TIP; PISTON SYRINGE Back to Search Results
Catalog Number 300912
Device Problem Fungus in Device Environment (2316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd 10ml syringe luer-lok¿ tip had mold on it.This was discovered before use.The following information was provided by the initial reporter: when preparing medication for the administration of medication, the customer noticed that the syringe contained dirt and can not be used.According to him appears to contain fungal infection (such as mold).
 
Manufacturer Narrative
H.6.Investigation: two 10ml syringes were received and evaluated.It was observed one syringe was in a fully sealed blister pack confirmed to be from batch 8268985 (b)(4) with no visual defects.One syringe was loose with an orange tip cap attached and 2ml of clear fluid inside.It appeared there was a small amount of damage on one of the ribs of the plunger rod near the top causing a buildup of plastic fibers consistent with the reported "mold".The foreign matter plastic fibers are larger than level 3 in size and were rejectable per product specification.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.Potential root cause for the foreign matter defect is associated with the assembly process.H3 other text : see h.10.
 
Event Description
It was reported that bd 10ml syringe luer-lok¿ tip had mold on it.This was discovered before use.The following information was provided by the initial reporter: when preparing medication for the administration of medication, the customer noticed that the syringe contained dirt and can not be used.According to him appears to contain fungal infection (such as mold).
 
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Brand Name
BD 10ML 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 Key8851745
MDR Text Key153849736
Report Number1213809-2019-00798
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903009122
UDI-Public30382903009122
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2023
Device Catalogue Number300912
Device Lot Number8268985
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2019
Date Manufacturer Received07/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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