MINILOC SAFETY INFUSION SET 20G X 1 IN S02020-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for MINILOC SAFETY INFUSION SET 20G X 1 IN S02020-10 manufactured by Bard Access Systems.

Event Text Entries

[119654703] 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 has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) of asbus0197 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (asbus0197) have been reported from the same facility in (b)(4). Device has not yet been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[119654704] It was reported that during the internal inspection, two device units had unidentified colorless materials blocking the infusion tubes. The devices were not used on a patient. This report addresses the first device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006260740-2018-02369
MDR Report Key7852957
Date Received2018-09-06
Date of Report2018-11-13
Date of Event2018-06-07
Date Mfgr Received2018-11-13
Device Manufacturer Date2017-07-01
Date Added to Maude2018-09-06
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 ContactKELSEY ERICKSON
Manufacturer Street605 N. 5600 W.
Manufacturer CitySALT LAKE CITY UT 84116
Manufacturer CountryUS
Manufacturer Postal84116
Manufacturer Phone8015225937
Manufacturer G1BARD ACCESS SYSTEMS
Manufacturer Street605 N. 5600 W.
Manufacturer CitySALT LAKE CITY UT 84116
Manufacturer CountryUS
Manufacturer Postal Code84116
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMINILOC SAFETY INFUSION SET 20G X 1 IN
Generic NameSET, ADMINISTRATION, INTRAVASCULAR
Product CodeFON
Date Received2018-09-06
Returned To Mfg2018-10-29
Catalog NumberS02020-10
Lot NumberASBUS0197
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBARD ACCESS SYSTEMS
Manufacturer Address605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-06

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