BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE UNKNOWN manufactured by Becton Dickinson.

Event Text Entries

[110453346] The date received by manufacturer has been used. Medical device manufacturer: unknown. Bd corporate headquarters in (b)(4) has been listed. Manufacturing location: unknown. Bd corporate headquarters in (b)(4)has been listed. Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. Additionally, bd was unable to determine the specific lot number associated with this complaint. Therefore, a review of the device history record could not be conducted.
Patient Sequence No: 1, Text Type: N, H10


[110453347] It was reported that bd vacutainer? Urine analysis preservative tube had "erroneous results" no report of injury or medical intervention. No report of blood exposure to mucous membrane.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243072-2018-01054
MDR Report Key7575406
Date Received2018-06-06
Date of Report2018-05-11
Date of Event2016-11-07
Date Mfgr Received2016-11-07
Date Added to Maude2018-06-06
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
Manufacturer Street1 BECTON DRIVE
Manufacturer CityFRANKLIN LAKES NJ 07417
Manufacturer CountryUS
Manufacturer Postal Code07417
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE
Generic NameSPECIMEN TRANSPORT AND STORAGE CONTAINER
Product CodeKDW
Date Received2018-06-06
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON
Manufacturer Address1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-06-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.