WALKMED 65 ML RESERVOIR BAG 204820 #IPR-86

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-04-04 for WALKMED 65 ML RESERVOIR BAG 204820 #IPR-86 manufactured by Walkmed Infusion, Llc.

Event Text Entries

[71712791] (b)(4). A separate mdr report was generated for the three (3) patients who were using 5fu medication at the time of the events on (b)(6) 2017. An mdr report was not generated for the pharmacist who discovered the leak during set up, as it was determined that there was no potential exposure to hazardous medication related to that particular event and no indication that there would be potential for serious injury if that particular event were to recur. The actual device was returned to rexmed, not walkmed, on 03/03/2017. Rexmed opened a complaint, # (b)(4) and investigated the device. Rexmed confirmed a leak in the device luer lock but could not determine a root cause. Nevertheless as a containment action, rexmed is checking that the luer lock has no fissure damage before the reservoir bag has been sent.
Patient Sequence No: 1, Text Type: N, H10


[71712792] There were 4 individual events involving a leak with 4 different walkmed infusion's ipr bags from lot 20816500 (ref 204820, lot 20816500). Each event involved one person, for a total four (4) people. A total of three patients were exposed to medication during their treatment (on (b)(6) 2017 two patients were affected and on (b)(6) 2017 one patient was affected). Yes 5fu was being administered. The leak was coming from the site between the luer lock and the tubing connected to the ipr bag. Additionally, on (b)(6) 2017 a pharmacist found the leak before given to patient, no 5fu with this one so there was no possible chemical exposure. No injuries to patient or staff.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723533-2017-00003
MDR Report Key6458065
Report SourceUSER FACILITY
Date Received2017-04-04
Date of Event2017-02-01
Date Mfgr Received2017-03-03
Date Added to Maude2017-04-04
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 ContactMR THOMAS ASSANTE
Manufacturer Street6555 S KENTON ST SUITE 304
Manufacturer CityCENTENNIAL CO 80111
Manufacturer CountryUS
Manufacturer Postal80111
Manufacturer Phone7203514944
Manufacturer G1REXMED
Manufacturer StreetFRESNEL # 8375 PARQUE INDUSTRIAL BERM
Manufacturer CityJUAREZ, CHIHUAHUA 32470
Manufacturer CountryMX
Manufacturer Postal Code32470
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWALKMED 65 ML RESERVOIR BAG
Generic NameRESERVOIR BAG
Product CodeBTC
Date Received2017-04-04
Returned To Mfg2017-03-03
Model Number204820
Catalog Number#IPR-86
Lot Number20816500
OperatorPHARMACIST
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerWALKMED INFUSION, LLC
Manufacturer Address6555 S KENTON ST SUITE 304 SUITE 304 CENTENNIAL CO 80111 US 80111


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-04-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.