QUICKLINK? CARTRIDGE 5.0MM EXTENSION SOURCELINK? 70303QC20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-21 for QUICKLINK? CARTRIDGE 5.0MM EXTENSION SOURCELINK? 70303QC20 manufactured by Bard Brachytherapy, Inc. -1424526.

Event Text Entries

[103286365] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[103286366] It was reported that after compacting a train of extension, the seed train hung in the end of the quicklink. It was noted that the tip of the extension was crushed. Two attempts later, the expansion bar was changed to eliminate a batch problem, however the issue persisted. The quicklink was then changed, and so was the extension bar, in addition to compressing the grain train at a slower pace.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2018-00893
MDR Report Key7356729
Date Received2018-03-21
Date of Report2018-05-18
Date of Event2018-02-19
Date Mfgr Received2018-05-18
Device Manufacturer Date2017-09-22
Date Added to Maude2018-03-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAMY GRAVLEY
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1BARD BRACHYTHERAPY, INC. -1424526
Manufacturer Street295 EAST LIES ROAD
Manufacturer CityCAROL STREAM IL 60188
Manufacturer CountryUS
Manufacturer Postal Code60188
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameQUICKLINK? CARTRIDGE 5.0MM EXTENSION SOURCELINK?
Generic NameBRACHYTHERAPY
Product CodeKXK
Date Received2018-03-21
Model Number70303QC20
Catalog Number70303QC20
Lot NumberBBBV0102
Device Expiration Date2018-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBARD BRACHYTHERAPY, INC. -1424526
Manufacturer Address295 EAST LIES ROAD CAROL STREAM IL 60188 US 60188


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-21

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