NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO 302047

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 2020-03-18 for NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO 302047 manufactured by Bd Medical (bd West) Medical Surgical.

Event Text Entries

[186324937] Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Investigation summary: one photo was provided. It shows two needle assemblies without the plastic shield. One has the needle with normal finishing/ color; the other is blackened. The etching cannula may had a variation creating this unit with discoloration. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. A device history record review was completed with zero defects found. No quality notifications were written for this batch, nor for the associated assembly batches. Investigation conclusion: this is the 1st complaints for the lot # 8204928 for the same defect or symptom. There was no documentation for this type of defects during the entire production run of this batch. Root cause description: cannula process. The etching cannula may had a variation creating this unit with discoloration. Rationale: capa required not this time.
Patient Sequence No: 1, Text Type: N, H10


[186324938] It was reported that needle ns 30ga 1/2in bns yel hub tw euro contained foreign matter. The following information was provided by the initial reporter: "blackened needles were founded in the visual inspection blackened 10 needles / 500 needles inspected (2%). "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1911916-2020-00271
MDR Report Key9850776
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-18
Date of Report2020-03-09
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2018-07-23
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 G1BD MEDICAL (BD WEST) MEDICAL SURGICAL
Manufacturer Street1852 10TH AVENUE
Manufacturer CityCOLUMBUS NE 68601
Manufacturer CountryUS
Manufacturer Postal Code68601
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO
Generic NameNEEDLE
Product CodeFMI
Date Received2020-03-18
Catalog Number302047
Lot Number8204928
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBD MEDICAL (BD WEST) MEDICAL SURGICAL
Manufacturer Address1852 10TH AVENUE COLUMBUS NE 68601 US 68601


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-18

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