BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364941

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364941 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[108992001] Date of event: unknown. Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation. The photos 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. Bd has initiated further investigation relating to this issue through a situation analysis and potential causes have been identified. As a result, corrective actions have been established and are in the process of being implemented. Investigation conclusion: based on evaluation of the customer photos, the customer? S indicated failure mode for missing cannula with the incident lot was observed. Further investigation activities have been conducted through a situation analysis and the most likely root cause has been identified. As a result, corrective actions and procedures are being implemented to mitigate further occurrences. Root cause description: a situation analysis was conducted to document further investigation and root cause analysis relating to this issue. The investigation has identified the most likely root causes and corrective actions are in the process of being implemented. Rationale: based on an assessment of severity and frequency, it was determined that a situation analysis is required at this time in order to determine the root cause associated with this issue. The investigation has identified potential root cause(s) for this issue and corrective actions are in the process of being implemented.
Patient Sequence No: 1, Text Type: N, H10


[108992002] It was reported that the transfer needle of the bd vacutainer? Plastic urine collection cup is missing, therefore the cups cannot be used and leak found before use. No reports of serious injury or medical intervention noted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2018-00191
MDR Report Key7530165
Date Received2018-05-21
Date of Report2018-05-17
Date of Event2018-05-03
Date Mfgr Received2018-05-03
Device Manufacturer Date2017-12-08
Date Added to Maude2018-05-21
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 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? PLASTIC URINE COLLECTION CUP
Generic NameURINE COLLECTION CUP
Product CodeJTW
Date Received2018-05-21
Catalog Number364941
Lot Number7342787
Device Expiration Date2019-11-30
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON AND COMPANY (BD)
Manufacturer AddressBELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-21

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