TRIPLE-PORT GASTROSTOMY TUBE E3316

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2000-11-02 for TRIPLE-PORT GASTROSTOMY TUBE E3316 manufactured by Rusch, Inc..

Event Text Entries

[17514927] It is alleged that the connector port of the gastrostomy tubes stretch and, in some cases, break.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2429473-2000-00097
MDR Report Key303931
Report Source08
Date Received2000-11-02
Date Mfgr Received2000-10-24
Date Added to Maude2000-11-14
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
Manufacturer ContactKATRINA HALBIG, QUALITY ADMIN
Manufacturer Street2450 MEADOWBROOK PARKWAY
Manufacturer CityDULUTH GA 30136
Manufacturer CountryUS
Manufacturer Postal30136
Manufacturer Phone7706230816
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRIPLE-PORT GASTROSTOMY TUBE
Generic NameGASTROSTOMY CATHETER
Product CodeKDH
Date Received2000-11-02
Returned To Mfg2000-06-06
Model NumberNA
Catalog NumberE3316
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key294140
ManufacturerRUSCH, INC.
Manufacturer Address2450 MEADOWBROOK PARKWAY DULUTH GA 30096 US
Baseline Brand NameTRIPLE-PORT GASTROSTOMY CATHETERS
Baseline Generic NameGASTROSTOMY CATHETER
Baseline Model NoNA
Baseline Catalog NoE3316
Baseline IDNA
Baseline Device FamilyGASTROSTOMY CATHETER
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK891371
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2000-11-02

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