UNSPECIFIED BD PEN NEEDLE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-18 for UNSPECIFIED BD PEN NEEDLE UNKNOWN manufactured by Becton Dickinson.

Event Text Entries

[188029468] 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. Initial reporter phone #: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10


[188029469] It was reported that during use the non patient end of the cannula breaks with an unspecified bd pen needle. The following information was provided by the initial reporter: it was reported that the rear cannula end is broken and gets stuck.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243072-2020-00434
MDR Report Key9850348
Report SourceDISTRIBUTOR,OTHER
Date Received2020-03-18
Date of Report2020-03-25
Date of Event2020-02-27
Date Mfgr Received2020-02-27
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 BD PEN NEEDLE
Generic NameHYPODERMIC SINGLE LUMEN NEEDLE
Product CodeFMI
Date Received2020-03-18
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
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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