BD VACUTAINER? URINE COLLECTION CONTAINER, SCREW CLOSURE 364941

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-19 for BD VACUTAINER? URINE COLLECTION CONTAINER, SCREW CLOSURE 364941 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[124547230] (b)(6). Investigation summary: bd received samples from the customer facility for investigation. The samples were evaluated and the customer's indicated failure mode for missing cannula with the incident lot was observed. A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product. Investigation conclusion : based on evaluation of the customer samples, the customer? S indicated failure mode for missing cannula with the incident lot was observed. Root cause description : based on the investigation, the most likely root cause was determined to be related to a manufacturing issue. As a result, bd is reviewing specific areas in the manufacturing process where the cause of this issue may have originated. Rationale : complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
Patient Sequence No: 1, Text Type: N, H10


[124547231] It was reported that bd vacutainer? Urine collection container, the needles in the cups are missing. There was no report of exposure, serious injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2018-02900
MDR Report Key7985192
Date Received2018-10-19
Date of Report2018-09-28
Date of Event2018-09-26
Date Mfgr Received2018-09-25
Device Manufacturer Date2017-12-08
Date Added to Maude2018-10-19
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 Phone8015652845
Manufacturer G1BECTON, DICKINSON AND COMPANY (BD)
Manufacturer StreetBELLIVER WAY BELLIVER INDUSTRIAL ESTATE
Manufacturer CityPLYMOUTH
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBD VACUTAINER? URINE COLLECTION CONTAINER, SCREW CLOSURE
Generic NameSPECIMEN TRANSPORT AND STORAGE CONTAINER
Product CodeJTW
Date Received2018-10-19
Returned To Mfg2018-10-11
Catalog Number364941
Lot Number7342787
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON AND COMPANY (BD)
Manufacturer AddressBELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-10-19

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