UNSPECIFIED EDTA VACUTAINER BLOOD COLLECTION TUBE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-18 for UNSPECIFIED EDTA VACUTAINER BLOOD COLLECTION TUBE UNKNOWN manufactured by Becton Dickinson.

Event Text Entries

[186285098] Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd had not received samples or photos from the customer facility for evaluation. 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


[186285099] It was reported after use an unspecified bd edta tube had erroneous results. The following information was provided by the initial reporter: "edta (both sizes) had false neg & pos results for hgb,mcb, hematocrit".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243072-2020-00421
MDR Report Key9848902
Report SourceOTHER,USER FACILITY
Date Received2020-03-18
Date of Report2020-03-19
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Phone8015652341
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 Report3

Device Details

Brand NameUNSPECIFIED EDTA VACUTAINER BLOOD COLLECTION TUBE
Generic NameBLOOD SPECIMEN COLLECTION DEVICE
Product CodeJKA
Date Received2020-03-18
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
Device Availability*
Device AgeDA
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 2020-03-18

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