120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364975

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2017-01-13 for 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364975 manufactured by Becton, Dickinson & Co..

Event Text Entries

[64766585] Results: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer? S indicated failure mode. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[64766586] It was reported that a healthcare worker in a patient's hospital room stuck himself/herself with a contaminated lid of a used 120 ml bd vacutainer? Plastic urine collection cup while disposing of it in a sharps container. The employee was evaluated by employee health but did not receive any post exposure lab work or any other medical interventions.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2017-00006
MDR Report Key6249473
Report SourceHEALTH PROFESSIONAL,OTHER,USE
Date Received2017-01-13
Date of Report2017-01-10
Date of Event2016-04-15
Date Mfgr Received2016-12-22
Date Added to Maude2017-01-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBDX BRETT WILKO
Manufacturer Street9450 SOUTH STATE STREET
Manufacturer CitySANDY UT 84070
Manufacturer CountryUS
Manufacturer Postal84070
Manufacturer Phone8015652845
Manufacturer G1BECTON, DICKINSON & CO.
Manufacturer Street150 SOUTH 1ST AVENUE
Manufacturer CityBROKEN BOW NE 68822
Manufacturer CountryUS
Manufacturer Postal Code68822
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP
Generic NameCOLLECTION CUP
Product CodeJXA
Date Received2017-01-13
Catalog Number364975
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerBECTON, DICKINSON & CO.
Manufacturer Address150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-01-13

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