FLEXIMA APDL 30935

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-02 for FLEXIMA APDL 30935 manufactured by Boston Scientific Corporation.

Event Text Entries

[143848360] Date of event was not provided.
Patient Sequence No: 1, Text Type: N, H10


[143848361] It was reported that the catheter drainage hub broke at the chest. The target area was located in the right lower lobe. A flexima apdl drainage catheter was selected for use. During the procedure, it was noted that the hub broke. The physician tried to remove the rube without unlocking the pigtail. Furthermore, there was leak noted in the bed. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2019-04696
MDR Report Key8573680
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-02
Date of Report2019-07-05
Date of Event2019-03-27
Date Mfgr Received2019-06-13
Date Added to Maude2019-05-02
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
Manufacturer Street2546 CALLE PRIMERA PROPARK, COYOL
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXIMA APDL
Generic NameTUBE, DRAINAGE, SUPRAPUBIC
Product CodeFFA
Date Received2019-05-02
Returned To Mfg2019-05-16
Model Number30935
Catalog Number30935
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-02

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