"D" BAG DRAINAGE SET DBAG600

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 2011-05-04 for "D" BAG DRAINAGE SET DBAG600 manufactured by Angiotech, Medical Device Technologies.

Event Text Entries

[22094456] The customer reported the pouch is drilled.
Patient Sequence No: 1, Text Type: D, B5


[22257316] The product was returned for review. The seal of the pouch is complete. There is a straight cut measuring 3 inches on the poly side of the pouch. This product is packaged twenty to a box. The two flaps on the end of the box are folded over and taped. If a cutting utensil is used to open the box and is pushed deep enough while cutting the tape, the top pouch may be cut as seen on the returned pouch. This is the first report of this occurring. The defect is readily visible by the customer. We will continue to monitor and trend to take action when necessary.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1036710-2011-00005
MDR Report Key2097432
Report Source08
Date Received2011-05-04
Date of Report2011-04-11
Date of Event2011-04-11
Date Mfgr Received2011-04-11
Device Manufacturer Date2010-08-01
Date Added to Maude2012-03-29
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 FDA0
Event Location0
Manufacturer ContactSHANNON BROOKS, SR QUALITY ANALYS
Manufacturer Street3600 S.W. 47TH AVE.
Manufacturer CityGAINESVILLE FL 32608
Manufacturer CountryUS
Manufacturer Postal32608
Manufacturer Phone3523380440
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name"D" BAG DRAINAGE SET
Generic NameDRAINAGE SET
Product CodeEXF
Date Received2011-05-04
Returned To Mfg2011-04-25
Model NumberDBAG600
Catalog NumberNA
Lot Number030823VI
ID NumberNA
Device Expiration Date2015-11-30
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
Manufacturer Address3600 SW 47TH AVE. GAINESVILLE FL 32608 US 32608


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-05-04

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