TPLC - Total Product Life Cycle

• Device: set, administration, intravascular
• Regulation Description: Intravascular administration set.
• Product Code: FPA
• Regulation Number: 880.5440
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	1
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	3
AARON MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ABBOTT
	SUBSTANTIALLY EQUIVALENT	31
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCE MEDICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ALARIS MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANIMAS
	SUBSTANTIALLY EQUIVALENT	1
ARROW INTL., INC.
	SUBSTANTIALLY EQUIVALENT	2
AVAIL MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	17
BALLARD MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
BAXA CORP.
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	52
BD
	SUBSTANTIALLY EQUIVALENT	4
BIOMEDIX
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	5
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	2
CARDIOMED
	SUBSTANTIALLY EQUIVALENT	1
CHURCHILL MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	7
CODAN US CORP.
	SUBSTANTIALLY EQUIVALENT	5
CONMED
	SUBSTANTIALLY EQUIVALENT	1
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	3
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	1
DEKA RESEARCH & DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
DIATEK, INC.
	SUBSTANTIALLY EQUIVALENT	4
DISETRONIC MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
DRAGON HEART MEDICAL DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ELCAM MEDICAL A.C.A.L.
	SUBSTANTIALLY EQUIVALENT	1
EPIMED
	SUBSTANTIALLY EQUIVALENT	1
EXCELSIOR MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
EXELINT INTERNATIONAL CO
	SUBSTANTIALLY EQUIVALENT	6
EXELINT INTERNATIONAL CO.
	SUBSTANTIALLY EQUIVALENT	2
E-Z-EM, INC.
	SUBSTANTIALLY EQUIVALENT	3
FRESENIUS
	SUBSTANTIALLY EQUIVALENT	1
GISH BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GO MEDICAL INDUSTRIES PTY. LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUIDANT CORP
	SUBSTANTIALLY EQUIVALENT	1
HAEMONETICS CORP.
	SUBSTANTIALLY EQUIVALENT	2
HARMAC MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
HEALTH LINE INTERNATIONAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
HORIZON MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOSPIRA INC.
	SUBSTANTIALLY EQUIVALENT	2
HOSPIRA, INC.
	SUBSTANTIALLY EQUIVALENT	5
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
I FLOW CORP
	SUBSTANTIALLY EQUIVALENT	9
ICU MEDICAL SALES, INC.
	SUBSTANTIALLY EQUIVALENT	25
IMED CORP.
	SUBSTANTIALLY EQUIVALENT	12
INNOVATIVE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
JMS
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SUBSTANTIALLY EQUIVALENT	3
LABORATOIRES PEROUSE
	SUBSTANTIALLY EQUIVALENT	1
LEVEL 1
	SUBSTANTIALLY EQUIVALENT	1
LEVENTON, S.A.
	SUBSTANTIALLY EQUIVALENT	1
Lifemed of California
	SUBSTANTIALLY EQUIVALENT	2
MAERSK MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
MANAN MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MARCAL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MARQUETTE
	SUBSTANTIALLY EQUIVALENT	11
McKinley Medical, LLP
	SUBSTANTIALLY EQUIVALENT	1
MEDCOMP
	SUBSTANTIALLY EQUIVALENT	1
MEDEGEN
	SUBSTANTIALLY EQUIVALENT	5
MEDEX
	SUBSTANTIALLY EQUIVALENT	9
MEDIKMARK, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDISYSTEM
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	14
MEINNTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
MIGADA PLANT
	SUBSTANTIALLY EQUIVALENT	1
MULTI-MED, INC.
	SUBSTANTIALLY EQUIVALENT	3
NAMIC
	SUBSTANTIALLY EQUIVALENT	1
NEXUS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	11
NIPRO CORP
	SUBSTANTIALLY EQUIVALENT	6
NORFOLK MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
NORTHGATE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PENTAFERTE S.P.A
	SUBSTANTIALLY EQUIVALENT	1
PFM MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	2
PRIMROSE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
QUEST MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
RETRACTABLE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
RYMED TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
SABRATEK
	SUBSTANTIALLY EQUIVALENT	1
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
SMITHS
	SUBSTANTIALLY EQUIVALENT	15
SPECIALIZED HEALTH PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	11
TIANJIN MEDIS INTERNATIONAL TRADE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNOMEDICAL
	SUBSTANTIALLY EQUIVALENT	6
VALLEYLAB
	SUBSTANTIALLY EQUIVALENT	4
VENETEC
	SUBSTANTIALLY EQUIVALENT	2
VENUSA LTD.
	SUBSTANTIALLY EQUIVALENT	5
VIDACARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VLV ASSOCIATES, INC.
	SUBSTANTIALLY EQUIVALENT	8
VYGON CORP.
	SUBSTANTIALLY EQUIVALENT	2
W.L. GORE & ASSOCIATES,INC
	SUBSTANTIALLY EQUIVALENT	1
WARNER-LAMBERT CO.
	SUBSTANTIALLY EQUIVALENT	1
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZYNO MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Fluid leak	693
Material separation	436
Leak	262
Failure to deliver	201
Disconnection	189
Overdelivery	183
Valve(s), failure of	132
Break	122
Accuracy rate	105
Reflux within device	102
Air leak	89
Material rupture	83
Unknown (for use when the device problem is not known)	63
Excess flow or overinfusion	51
Sticking	43
Tube(s), defective	42
Device, or device fragments remain in patient	33
Other (for use when an appropriate device code cannot be identified)	32
Infusion or flow issue	31
Component(s), broken	31
Crack	30
Detachment of device component	29
Material puncture	27
Insufficient flow or underinfusion	26
Difficult or delayed activation	25
Free or unrestricted flow	24
No Information	23
Particulates	22
Kinked	16
Tears, rips, holes in device, device material	14
Inaccurate flowrate	14
Inaccurate delivery	14
Occlusion within device	13
Hole in material	13
Tube(s), buckling of	13
Underdelivery	11
Use of Device Issue	8
Improper flow or infusion	8
Cut in material	7
Device contamination with blood or blood product	6
Difficult to remove	6
Defective item	5
Failure to prime	5
Failure to reset	5
Structural problem	4
Difficult to insert	4
Bleed back	4
Defective component	4
Restricted flowrate	4
Device damaged prior to use	3
Rupture, cause unknown	3
Device inoperable	3
Improper or incorrect procedure or method	3
Replace	3
Precipitate in device or device ingredient	3
Misassembled	3
Instruction for use issue	3
Tube(s), splitting of	3
Difficult to flush	3
Blockage within device or device component	2
Device clogged	2
Failure to infuse	2
Hose line rupture	2
Device Difficult to Setup or Prepare	2
Leaflet disc escape	2
Device Issue	2
Unable to obtain readings	2
Needle, unsheathed	2
No flow	2
Bubble(s)	2
Peeled	2
Malfunction	2
Loose or intermittent connection	2
Port leak(s)	1
Self-activation or keying	1
Naturally worn	1
Blood in tubing	1
Collapse	1
Connection error	1
Device emits odor	1
Alarm, audible	1
Explode	1
Retraction problem	1
Component missing	1
Method, improper/incorrect	1
Bacterial contamination of device	1
Foreign material	1
Device-device incompatibility	1
Detachment of device or device component	1
No Known Device Problem	1
Failure to shut off	1
Device alarm system issue	1
Material deformation	1
Dissatisfaction	1
Filling problem	1
Increase in suction	1
Fracture	1
Obstruction within device	1
Suture line disruption	1
Failure to flush	1
Total Device Problems	3392

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	1	5	0	1	0
Class II	9	4	5	10	7	9	3
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Arizant Healthcare, Inc	II	Aug-18-2007
2	Arrow International Inc	I	Mar-30-2010
3	Arrow International Inc	II	Jun-24-2009
4	B. Braun Medical, Inc.	II	Jan-26-2010
5	B. Braun Medical, Inc.	II	Jun-05-2009
6	B. Braun Medical, Inc.	II	Oct-24-2008
7	B. Braun Medical, Inc.	II	Sep-23-2008
8	B. Braun Medical, Inc.	II	May-31-2007
9	Bard Access Systems	II	Feb-26-2010
10	Baxter Healthcare Corp.	II	May-07-2013
11	Baxter Healthcare Corp.	I	Oct-09-2012
12	Baxter Healthcare Corp.	II	Jan-11-2012
13	Baxter Healthcare Corp.	II	Aug-03-2011
14	Baxter Healthcare Corp.	II	Jul-15-2011
15	Baxter Healthcare Corp.	II	Jun-29-2011
16	Baxter Healthcare Corp.	II	Dec-01-2010
17	Baxter Healthcare Corp.	II	Oct-27-2010
18	Baxter Healthcare Corp.	II	Oct-15-2010
19	Baxter Healthcare Corp.	II	Dec-09-2009
20	Baxter Healthcare Corp.	II	Mar-14-2007
21	Becton Dickinson Medical Systems	I	Feb-02-2010
22	C.R. Bard, Inc., Urological Division	II	Jun-29-2009
23	Cardinal Health 303 Inc DBA Alaris Products	II	Nov-08-2007
24	Carefusion 303 Inc	II	Feb-15-2013
25	Carefusion 303, Inc.	II	Jun-29-2011
26	Carmel Pharma, Inc.	II	Aug-22-2007
27	Churchill Medical Systems, Inc.	II	Mar-06-2013
28	Churchill Medical Systems, Inc.	II	Feb-16-2011
29	Churchill Medical Systems, Inc.	II	May-21-2010
30	ConMed Corporation	II	Jan-11-2012
31	ConMed Corporation	II	Jan-11-2012
32	Curlin Medical Llc	II	Aug-07-2007
33	Exelint International Co.	I	Jan-22-2010
34	Hospira Inc.	II	Jul-25-2012
35	Hospira Inc.	II	Jan-19-2012
36	Hospira Inc.	II	Nov-25-2011
37	Hospira Inc.	II	Sep-29-2010
38	Hospira Inc.	II	Apr-15-2010
39	Hospira Inc.	II	Mar-09-2010
40	Hospira Inc.	II	Feb-22-2010
41	Hospira Inc.	II	Feb-27-2007
42	ICU Medical, Inc.	II	Jan-11-2012
43	ICU Medical, Inc.	II	Aug-16-2007
44	Medical Action Industries Inc	I	Mar-30-2010
45	Medical Product Specialist Inc dba MPS Acacia	I	Mar-30-2010
46	Medical Specialties Distributors, Inc.	II	Aug-09-2012
47	Medrad Inc	II	Dec-20-2012
48	Medtronic MiniMed	I	Jul-16-2009
49	Medtronic Minimed	II	Nov-17-2011
50	Merit Medical Systems, Inc.	II	Sep-11-2008
51	Smiths Medical ASD, Inc.	II	Jan-17-2012
52	Smiths Medical MD, Inc.	II	Apr-20-2009
53	Smiths Medical MD, Inc.	II	Feb-13-2008
54	Smiths Medical MD, Inc.	II	Aug-30-2007