BD VACUTAINER? NO ADDITIVE (Z) TUBES 366703

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-07 for BD VACUTAINER? NO ADDITIVE (Z) TUBES 366703 manufactured by Becton, Dickinson & Co..

Event Text Entries

[110615205] Date of event: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. 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


[110615206] It was reported that the bd vacutainer? No additive (z) tubes power processor was having trouble decapping their non additive tube (366703). As a result, the probes were crashing into the top and causing analyzer downtime. 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 Number1917413-2018-02216
MDR Report Key7578754
Date Received2018-06-07
Date of Report2018-05-14
Date of Event2016-07-21
Date Mfgr Received2016-07-21
Date Added to Maude2018-06-07
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 Report0

Device Details

Brand NameBD VACUTAINER? NO ADDITIVE (Z) TUBES
Generic NameSPECIMEN TRANSPORT AND STORAGE CONTAINER
Product CodeKDW
Date Received2018-06-07
Catalog Number366703
Lot NumberUNKNOWN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON & CO.
Manufacturer Address150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-06-07

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