BD VACUTAINER? URINE COLLECTION CUP 364941

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-04 for BD VACUTAINER? URINE COLLECTION CUP 364941 manufactured by Bd Medical - Diabetes Care.

Event Text Entries

[183279486] Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[183279487] It was reported that about 20 bd vacutainer? Urine collection cups were not sterile. The following information was provided by the initial reporter: "following the use of the devices 364941 batch no. 9323754, we found a closure defect. About twenty vials were either fully or partially open. Cancelling all the sterility of the vials. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1920898-2020-00072
MDR Report Key9667199
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-02-04
Date of Report2020-01-16
Date of Event2020-01-16
Date Mfgr Received2020-01-16
Device Manufacturer Date2019-11-19
Date Added to Maude2020-02-04
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 G1BD MEDICAL - DIABETES CARE
Manufacturer Street1329 WEST HIGHWAY 6
Manufacturer CityHOLDREGE NE 68949
Manufacturer CountryUS
Manufacturer Postal Code68949
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD VACUTAINER? URINE COLLECTION CUP
Generic NameSPECIMEN TRANSPORT AND STORAGE CONTAINER
Product CodeJTW
Date Received2020-02-04
Catalog Number364941
Lot Number9323754
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBD MEDICAL - DIABETES CARE
Manufacturer Address1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-04

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