UNSPECIFIED BD? SPECIMEN COLLECTION DEVICE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-25 for UNSPECIFIED BD? SPECIMEN COLLECTION DEVICE UNKNOWN manufactured by Becton Dickinson.

Event Text Entries

[134332073] Date of event: unknown. Device expiration date: unknown. Device manufacture date: unknown. 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. (b)(4). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[134332074] It was reported that a unspecified bd? Specimen collection device leaked urine through the lid.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243072-2019-00112
MDR Report Key8279676
Date Received2019-01-25
Date of Report2019-02-13
Date of Event2019-01-07
Date Mfgr Received2019-01-07
Date Added to Maude2019-01-25
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
Manufacturer Street1 BECTON DRIVE
Manufacturer CityFRANKLIN LAKES NJ 07417
Manufacturer CountryUS
Manufacturer Postal Code07417
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNSPECIFIED BD? SPECIMEN COLLECTION DEVICE
Generic NameSPECIMEN COLLECTION DEVICE
Product CodeJTW
Date Received2019-01-25
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 2019-01-25

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