RUSCH EZ-BLOCKER KIT MG-02770-002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-22 for RUSCH EZ-BLOCKER KIT MG-02770-002 manufactured by Teleflex Medical.

Event Text Entries

[151771778] (b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. The manufacturer (cmi) reports that they performed a dhr review of lot#636346. There were two eco's found; however, they have no impact on the reported defect. Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature. If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10


[151771779] It was reported that "when using on the patient, only one side of the balloon is strange. Can't balloon even if giving the same volume. " inflation issue was found prior to use on a patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011137372-2019-00222
MDR Report Key8813033
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-22
Date of Report2019-06-26
Date of Event2019-01-23
Date Mfgr Received2019-08-29
Date Added to Maude2019-07-22
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 ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal Code27560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUSCH EZ-BLOCKER KIT
Generic NameEZ BLOCKER
Product CodeCBI
Date Received2019-07-22
Returned To Mfg2019-08-13
Catalog NumberMG-02770-002
Lot Number636346
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressATHLONE


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-22

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