MAUDE MDR 117140

MDR report key: 117140
Report number: MW1012005
Event key: 0
Event type: 3
Date of event: 1997-08-06
Date received: 1997-08-25
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 401
Health professional: 3
Initial report to FDA: 0
Event location: 3

Manufacturer Contact#

Report source: P
Manufacturer link flag: N

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	DAVOL	BILE BAG	BARD/DAVOL INC.	EXF	0015850	0015850	76EG2838			N		Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	1997-08-25	0	1. H; 2. O

Event Narratives#

D

Patient 1

"URINE" BAG DID NOT DRAIN PROPERLY. THE BAG HAS A FLUTTER VALUE ATTACHED TO THE WRONG END OF THE BAG. BILE BAG WAS IMPROPERLY MFG. THIS IS THE THIRD FAILURE OF THIS TYPE IN THE PAST 9 MONTHS.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00661613318038	Biliary Drainage Kit	Marlen Manufacturing And Development Co.	EXF	2026-05-03
00884450859773	Merit Drainage Depot™	Merit Medical Systems, Inc.	EXF	2025-05-29
10884450859770	Merit Drainage Depot™	Merit Medical Systems, Inc.	EXF	2025-05-29
00817640020479	Drainage Bag	URESIL, LLC	EXF	2022-06-03
20817640020473	Drainage Bag	URESIL, LLC	EXF	2022-06-03
00817640020554	Optimus Gravity Drainage Bag	URESIL, LLC	EXF	2021-11-04
00817640020561	Optimus Gravity Drainage Bag	URESIL, LLC	EXF	2021-11-04
10817640020551	Gravity Drainage Bag	URESIL, LLC	EXF	2021-11-04
10817640020568	Gravity Drainage Bag	URESIL, LLC	EXF	2021-11-04
H862PDC360	Drainage Bag	URESIL, LLC	EXF	2017-09-11
H862TC6000	Gravity Drainage Bag	URESIL, LLC	EXF	2017-09-11
H862TC600L0	Gravity Drainage Bag	URESIL, LLC	EXF	2017-09-11
H862PDC362	Gravity Drainage Bag	URESIL, LLC	EXF	2017-09-11
H862TC6002	Gravity Drainage Bag	URESIL, LLC	EXF	2017-09-11
H862TC600L2	Gravity Drainage Bag	URESIL, LLC	EXF	2017-09-11
00884450025604	Merit Drainage Depot™	Merit Medical Systems, Inc.	EXF	2016-11-03
10884450025601	Merit Drainage Depot™	Merit Medical Systems, Inc.	EXF	2016-11-03
00884450008256	Merit Drainage Depot™	Merit Medical Systems, Inc.	EXF	2016-09-24
00884450232231	Merit Drainage Depot™	Merit Medical Systems, Inc.	EXF	2016-09-24
10884450008253	Merit Drainage Depot™	Merit Medical Systems, Inc.	EXF	2016-09-24
10884450232238	Merit Drainage Depot™	Merit Medical Systems, Inc.	EXF	2016-09-24
00813079020004	Drainage Bag	REMINGTON MEDICAL, INC.	EXF	2016-09-21
20813079020008	Drainage Bag	REMINGTON MEDICAL, INC.	EXF	2016-09-21
00886333001422	Drainage Bag	ARGON MEDICAL DEVICES, INC.	EXF	2016-09-09
00886333001439	Drainage Bag	ARGON MEDICAL DEVICES, INC.	EXF	2016-09-09
20886333001426	Drainage Bag	ARGON MEDICAL DEVICES, INC.	EXF	2016-09-09
20886333001433	Drainage Bag	ARGON MEDICAL DEVICES, INC.	EXF	2016-09-09
00801741036873	VacuBag	Bard Access Systems, Inc.	EXF	2015-12-04
10801741036870	VacuBag	Bard Access Systems, Inc.	EXF	2015-12-04
00801741036880	Navarre	Bard Access Systems, Inc.	EXF	2015-11-20

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K003078	EXF	MERIT DRAINAGE DEPOT	Merit Medical Systems, Inc.	2000-12-11
510(k)	K990428	EXF	DRAINAGE BAG	Remington Medical, Inc.	1999-08-12
510(k)	K980005	EXF	MANAN D BAG	Medical Device Technologies, Inc.	1998-01-30
510(k)	K961986	EXF	MANAN D BAG	Manan Medical Products, Inc.	1997-03-13
510(k)	K963849	EXF	MANAN D BAG	Manan Medical Products, Inc.	1996-12-13

MAUDE MDR 117140

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#