AN-69 DIALYZER FIL-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1999-04-23 for AN-69 DIALYZER FIL-20 manufactured by Gambro Healthcare Inc..

Event Text Entries

[16264707] External blood leak at cap during treatment. No injury or intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010182-1999-00010
MDR Report Key220723
Report Source06,07
Date Received1999-04-23
Date of Report1999-04-23
Date of Event1999-03-24
Date Mfgr Received1999-03-24
Date Added to Maude1999-04-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAN-69 DIALYZER
Generic NameFILTRAL 20
Product CodeFJG
Date Received1999-04-23
Model NumberFIL-20
Catalog NumberFIL-20
Lot Number98A1461
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key214067
ManufacturerGAMBRO HEALTHCARE INC.
Manufacturer Address1185 OAK ST LKEWOOD CO 80215 US
Baseline Brand NameAN69 HOLLOW FIBER DIALYZER
Baseline Generic NameCAVH/D HEMOFILTRATION
Baseline Model NoNA
Baseline Catalog NoFIL-20
Baseline IDNA
Baseline Device FamilyHEMOFILTRATION
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]36
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK901368
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1999-04-23

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