PLEURX PLEURAL CATHETER MINI KIT 50-7050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-05-28 for PLEURX PLEURAL CATHETER MINI KIT 50-7050 manufactured by Carefusion, Inc.

Event Text Entries

[146346783] (b)(4) initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4). No sample was returned for analysis. Consequently, the investigation was not able to further evaluate the reported failure mode through a complaint sample analysis. A device history record review could not be completed as no batch number was provided. Without a sample, photograph or lot information the investigation was unable to confirm the failure mode nor identify a probable root cause. As the failure mode was unable to be confirmed nor a root cause able to be determined a corrective and/or preventive action could not be identified for this complaint. This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.
Patient Sequence No: 1, Text Type: N, H10


[146346784] The customer reported: i want to inform you about a defective valve. At first the nose was broken off, then later on it was noticed that the valve is leaking. The valve was changed. No patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1625685-2019-00040
MDR Report Key8645676
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-05-28
Date of Report2019-05-28
Date of Event2019-05-06
Date Mfgr Received2019-05-28
Date Added to Maude2019-05-28
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 ANNA WEHRHEIM
Manufacturer Street75 N. FAIRVIEW DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer G1CAREFUSION, INC
Manufacturer Street400 EAST FOSTER RD
Manufacturer CityMANNFORD OK 74044
Manufacturer CountryUS
Manufacturer Postal Code74044
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLEURX PLEURAL CATHETER MINI KIT
Generic NameAPPARATUS, SUCTION, PATIENT CARE
Product CodeDWM
Date Received2019-05-28
Catalog Number50-7050
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address400 EAST FOSTER RD MANNFORD OK 74044 US 74044


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-28

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