18" EXTENSION TUBE WITH CONNECTOR, STERILE 4A4194

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-27 for 18" EXTENSION TUBE WITH CONNECTOR, STERILE 4A4194 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[131598577] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[131598578] It was reported that the packaging was labeled for (b)(4) but contained the brown colored latex tubing which coincides with (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2018-06211
MDR Report Key8200602
Date Received2018-12-27
Date of Report2018-12-27
Date Mfgr Received2018-12-06
Date Added to Maude2018-12-27
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 ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name18" EXTENSION TUBE WITH CONNECTOR, STERILE
Generic NamePVC EXTENSION TUBING
Product CodeFAQ
Date Received2018-12-27
Returned To Mfg2018-12-21
Catalog Number4A4194
Lot NumberNGCV2806
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-27

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